FDA 510(k) Applications for Medical Device Product Code "HGX"
(Pump, Breast, Powered)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K200712 | A Cute Baby, Inc. | Rumble Tuff Electric Breast Pump | 04/17/2020 |
| K113315 | ACUTE IDEAS CO. LTD. | RUMBLE TUFF | 11/20/2012 |
| K973501 | AMEDA MEDIZINTECHNIK AG | EXPRESSE AND PREMIER POWERED BREAST PUMPS | 12/11/1997 |
| K221576 | Ameda, Inc. | Ameda Pearl Electric Breast Pump | 10/12/2022 |
| K203570 | Ameda, Inc. | Mya Joy PLUS Breast Pump | 04/22/2021 |
| K230672 | Annabella Ltd. | Annabella Breast Pump | 08/04/2023 |
| K212773 | ARDO Medical AG | ARDO Alyssa | 04/15/2022 |
| K230590 | ARDO Medical AG | ARDO Bellis | 03/30/2023 |
| K150721 | ARDO MEDICAL AG | ARDO Calypso Pro Powered Breast Pump | 06/17/2015 |
| K141742 | ARDO MEDICAL AG | ARDO CARUM AND CALYPSO POWERED BREAST PUMPS | 10/17/2014 |
| K172067 | Ardo medical AG | One Mum Pumpset | 11/29/2017 |
| K051413 | AVENT AMERICA, INC. | ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100 | 08/29/2005 |
| K052047 | AVENT AMERICA, INC. | ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 | 09/22/2005 |
| K173699 | Babyation, LLC | The Pump by Babyation | 04/04/2018 |
| K020375 | BAILEY MEDICAL ENGINEERING | THE NURTURE III BREAST PUMP | 05/03/2002 |
| K160274 | BISTOS CO., LTD. | Hi bebe plus | 09/01/2016 |
| K200675 | Bistos Co., Ltd. | Hi bebe super (Models BT-150S and BT-150L) | 02/10/2021 |
| K100929 | BLUE EGG CO | UNIMOM ALLEGRO | 06/16/2010 |
| K181863 | Chiaro Technology Limited | Elvie Pump | 10/10/2018 |
| K210936 | Chiaro Technology Limited | Elvie Stride | 08/25/2021 |
| K221708 | Cimilre Co., Ltd. | CIMILRE Free-T2 Plus | 12/23/2022 |
| K162870 | CIMILRE CO., LTD. | CIMLRE F1 and CIMILRE S3 | 03/07/2017 |
| K201903 | Cixi Ruihong Electric Appliance Co., Ltd. | Electric breast pump (Models: RH-228 and RH-338) | 04/09/2021 |
| K111411 | DAO HEALTH | FREEMIE (R) | 02/01/2012 |
| K130349 | DAO HEALTH | FREEMIE BREAST COLLECTION SYSTEM | 09/06/2013 |
| K172772 | DAO Health | Freemie Independence, Freemie Liberty | 10/13/2017 |
| K142168 | DEVON MEDICAL PRODUCTS, INC. | NATURE'S BOND 600 AND NATURE'S BOND 603 | 12/04/2014 |
| K212884 | Dongguan Rongfeng Medical Co., Ltd. | Electric breast pump | 01/20/2022 |
| K092783 | ENKO LTD. | DEBP | 10/22/2009 |
| K983776 | EVENFLO CO., INC. | EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP | 04/26/1999 |
| K960727 | EVENFLO CO., INC. | EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT | 02/14/1997 |
| K960726 | EVENFLO CO., INC. | EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP | 07/22/1996 |
| K100435 | EVENFLO COMPANY, INC. | AMEDA PLATINUM BREAST PUMP | 05/28/2010 |
| K022933 | EVENFLO COMPANY, INC. | EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT | 12/02/2002 |
| K082307 | EVENFLO COMPANY, INC. | EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT | 09/11/2008 |
| K052909 | EVENFLO COMPANY, INC. | EVENFLO ELAN BREAST PUMP | 11/01/2005 |
| K102600 | EVENFLO COMPANY, INC. | SIMPLYGO BREAST PUMP | 12/22/2010 |
| K092770 | EVENFLO COMPANY, INC. | SIMPLYGO HANDS FREE BREAST PUMP | 10/09/2009 |
| K131153 | EVENFLO FEEDING INCORPORATED | EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP | 06/18/2013 |
| K161266 | EXPLORAMED NC7, INC | Athena Breast Pump | 08/11/2016 |
| K191577 | Exploramed NC7, Inc. | Willow Wearable Breast Pump 2.0 | 09/06/2019 |
| K102516 | GENADYNE BIOTECHNOLOGIES, INC. | LUCINA MODEL MELODI | 08/11/2011 |
| K112856 | GENADYNE BIOTECHNOLOGIES, INC. | LUCINA-MELODI | 05/10/2012 |
| K143574 | Genadyne Biotechnologies, Inc. | Melodi Prime Breast Pump | 04/21/2015 |
| K043098 | GERBER PRODUCTS CO. | GERBER DOUBLE ELECTRIC BREAST PUMP | 12/15/2004 |
| K172842 | Globalcare | GCE704 Breast Pump | 06/18/2018 |
| K193449 | Guangdong Horigen Mother & Baby Products Co., Ltd | Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) | 09/11/2020 |
| K201152 | Guangdong Horigen Mother & Baby Products Co., Ltd. | Electric Breast Pump | 05/04/2021 |
| K212564 | Guangdong Horigen Mother & Baby Products Co., Ltd. | Electric Breast Pump | 05/06/2022 |
| K182413 | Guangdong Horigen Mother & Baby Products Co., Ltd. | Electric Breast Pump | 03/07/2019 |
| K162747 | Guangdong Horigen Mother & Baby Products Co., Ltd. | Proture Double Electric Breast Pump | 12/08/2016 |
| K150923 | Guangzhou Jinxinbao Electronic Co.,Ltd | Breast Pump | 11/06/2015 |
| K223329 | Guangzhou Yongyi Industrial Co., Ltd. | Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201) | 05/26/2023 |
| K192640 | Guangzhou Yongyi Industrial Co., Ltd. | Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump | 03/30/2020 |
| K211016 | Haenim Co., Ltd. | Powered Breast Pump (Models 7V and 7X) | 06/29/2022 |
| K230102 | Huizhou LVB Maternal And Infant Supplies Co,Ltd. | Smart double sides wearable breast pump, Electric bilateral breast pump | 09/21/2023 |
| K190465 | Hygeia II Medical Group, Inc. | Evolve Breast Pump | 10/18/2019 |
| K200406 | Hygeia II Medical Group, Inc. | Evolve Breast Pump | 03/18/2020 |
| K212955 | Hygeia II Medical Group, Inc. | Fit Pro Breast Pump | 03/15/2022 |
| K081932 | HYGEIA MEDICAL, INC. | ENDEARE BREAST PUMP | 01/22/2009 |
| K202045 | imani Co. | imani i1 | 02/26/2021 |
| K202037 | imani Co. | imani i2 | 03/01/2021 |
| K222573 | imani Co. | imani i2Plus Breast Pump | 03/03/2023 |
| K172989 | Joytech Healthcare Co., Ltd. | Electric Breast Pump | 12/20/2017 |
| K971543 | KAWECO GMBH | LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP | 09/18/1997 |
| K981549 | LACTATION TECHNIQUES, INC. | LACTATION TECHNIQUES MODEL B | 05/24/1999 |
| K230469 | Lansinoh Laboratories | Compact Wearable Pump | 06/30/2023 |
| K222726 | Lansinoh Laboratories | Smartpump 3.0 Double Electric Breast Pump | 12/23/2022 |
| K122474 | LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN | LANSINOH POWERED ELECTRIC BREAST PUMP | 12/28/2012 |
| K182749 | Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd | Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump | 06/12/2019 |
| K082802 | LEARNING CURVE BRANDS INC. THE FIRST YEARS | MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B | 10/09/2008 |
| K051926 | LIMERICK, INC. | LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP | 12/12/2005 |
| K021739 | LIMERICK, INC. | LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002 | 01/10/2003 |
| K012275 | LIMERICK, INC. | PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP | 01/07/2002 |
| K132220 | LIMERICK, INC. | PJ'S SERENITY | 02/20/2015 |
| K100385 | LUV N' CARE, LTD. | NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP | 03/24/2010 |
| K101157 | MAPA GMBH | E-BASIC SINGLE BREAST PUMP | 09/17/2010 |
| K121478 | MAPA GMBH | NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP | 04/05/2013 |
| K221598 | Mayborn (UK) Limited | Wearable breast pump | 12/09/2022 |
| K110343 | MAYBORN BABY AND CHILD / JACKEL INTERNATIONAL LTD | TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP | 03/11/2011 |
| K121322 | MAYBORN GROUP LIMITED | CLOSER TO NATURE | 05/31/2012 |
| K113664 | MAYBORN GROUP LIMITED | CLOSER TO NATURE ELECTRIC BREAST PUMP | 02/17/2012 |
| K081463 | MEDEL S.P.A. | MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP | 02/06/2009 |
| K150499 | MEDELA AG | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty | 04/21/2015 |
| K191653 | Medela AG | Freestyle Flex | 10/17/2019 |
| K053052 | MEDELA AG | MEDELA SWING BREAST PUMP | 05/02/2006 |
| K151632 | MEDELA AG | Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental | 11/05/2015 |
| K200508 | Medela LLC | Pump In Style | 06/15/2020 |
| K181937 | Medela LLC | Pump In Style Advanced, Advanced Personal Double Breastpump | 10/16/2018 |
| K210759 | Medela LLC | Solo, Swing Maxi | 08/11/2021 |
| K161725 | MEDELA, INC | Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail | 10/28/2016 |
| K031614 | MEDELA, INC. | MEDELA PUMP IN STYLE ADVANCED BREAST PUMP | 06/06/2003 |
| K020518 | MEDELA, INC. | MEDELA SYMPHONY BREAST PUMP, MODEL 024 | 03/07/2002 |
| K223084 | MilkMate Products, Inc. | MilkMate Breast Pump | 03/16/2023 |
| K170722 | Moxxly, Inc. | Moxxly Flow Collection System | 08/28/2017 |
| K163183 | Nantong Poly Technology Co., Ltd. | Yooeehouse Breast Pump | 10/02/2017 |
| K952712 | NATURAL TECHNOLOGIES, INC. | WHITE RIVER BATTERY-POWERED BREAST PUMP | 04/18/1996 |
| K160511 | NAYA HEALTH INC. | Naya Breast Pump System | 06/24/2016 |
| K191802 | Ningbo Huiyoo Baby Products Co. Ltd. | Electric Breast Pump | 01/16/2020 |
| K203148 | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030) | 07/08/2021 |
| K163136 | NINGBO YOUHE ELECTRICAL APPLIANCE TECHNOLOGY CO.,LTD. | Youha electric breast pump | 07/31/2017 |
| K203383 | Philips Consumer Lifestyle - Innovation Site Eindhoven | Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62 | 12/15/2020 |
| K201381 | Philips Consumer Lifestyle - Innovation Site Eindhoven | Philips Avent Single/Double electric breast pump Advanced | 10/01/2020 |
| K161532 | Philips Consumer Lifestyle-Innovation Site Eindhoven | Philips Avent Comfort Single/Twin Electric Breast Pump | 08/29/2016 |
| K022594 | PLAYTEX PRODUCTS, INC. | PLAYTEX BREAST PUMP | 11/01/2002 |
| K061013 | PLAYTEX PRODUCTS, INC. | PLAYTEX EMBRACE PETITE BREAST PUMP | 08/15/2006 |
| K211024 | Shantou Huihengqi Electronic Technology Co., Ltd. | Electric Breast Pump | 02/11/2022 |
| K132882 | SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD | ELECTRIC BREAST PUMP | 04/24/2014 |
| K143585 | SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD | Electric Breast Pump | 05/06/2015 |
| K223693 | Shenzhen Lutejiacheng Technology Co., Ltd. | Electric breast pump (model: M5) | 03/09/2023 |
| K230776 | Shenzhen Lutejiacheng Technology Co., Ltd. | Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro) | 06/09/2023 |
| K220309 | Shenzhen Lutejiacheng Technology Co., Ltd. | Wearable Breast Pump (Model S10) | 06/27/2022 |
| K212180 | Shenzhen TPH Technology Co., Ltd. | Wearable Breast Pump (Model S12) | 02/11/2022 |
| K223886 | Shenzhen TPH Technology Co., Ltd. | Wearable Breast Pump (Model S18) | 07/14/2023 |
| K220596 | Shenzhen TPH Technology Co., Ltd. | Wearable Breast Pump (Model S9) | 05/26/2022 |
| K222045 | Shenzhen TPH Technology Co.,Ltd. | Wearable Breast Pump (Model S1DW) | 01/04/2023 |
| K093648 | SIMPLISSE INC. | SIMPLISSE ELECTRIC BREASTFEEDING COMPANION | 07/14/2010 |
| K032566 | THE FIRST YEARS, INC. | NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP | 09/15/2003 |
| K033131 | THE FIRST YEARS, INC. | NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068 | 10/30/2003 |
| K964403 | THE FIRST YEARS, INC. | SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068) | 01/13/1997 |
| K964396 | THE NATURAL CHOICE CO., INC. | DOUBLE UP BREAST PUMP | 06/06/1997 |
| K131027 | TOMY INTERNATIONAL | MEMORY PUMP MODEL Y4947 | 05/30/2013 |
| K180075 | Unimom Co. | MINUET LCD, MINUET LCD eco | 08/06/2018 |
| K190810 | Unimom Co. | OPERA, OPERA eco | 08/30/2019 |
| K191208 | Uzinmedicare Co. | Spectra Cashmere | 10/11/2019 |
| K191109 | Uzinmedicare Co. | Spectra Q | 01/22/2020 |
| K150476 | UZINMEDICARE CO. | Spectra S1Plus and Spectra S2 Plus | 04/15/2016 |
| K181784 | Uzinmedicare Co. | Spectra S3 Plus | 11/30/2018 |
| K093145 | UZINMEDICARE CO. | SPECTRA SERIES BREAST PUMP | 08/13/2010 |
| K210124 | Uzinmedicare Co. | Synergy Gold (SG) Portable (Models MM011450 and MM011460) | 10/19/2021 |
| K220926 | Uzinmedicare Co., Ltd. | Spectra Wearable | 12/12/2022 |
| K162415 | Uzinmedicare Company | Spectra 9Plus | 03/15/2017 |
| K022140 | WHISPER WEAR | WHISPER WEAR BREAST PUMP | 09/30/2002 |
| K970488 | WHITE RIVER CONCEPTS | HYDROCHECK MICRO FILTER | 11/04/1997 |
| K964679 | WHITE RIVER CONCEPTS | WHITE RIVER AUTOMATIC BREAST PUMP | 06/10/1997 |
| K070435 | WHITTLESTONE, INC. | DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400 | 07/17/2007 |
| K002696 | WHITTLESTONE, INC. | WHITTLESTONE BREASTPUMP | 03/21/2001 |
| K051112 | WHITTLESTONE, INC. | WHITTLESTONE EXPRESSER | 09/07/2005 |
| K213311 | Willow Innovations, Inc. | Lucy Breast Pump | 02/09/2022 |
| K142479 | WUXI XINZHONGRUI BABY SUPPLIES CO., LTD. | MEGNA BREAST PUMPS | 02/24/2015 |
| K202802 | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | TT Electric Breast Pump, TT Double Electric Breast Pump | 08/26/2021 |
| K151284 | Wuxi Xinzhongrui Baby Supplies Co.,Ltd | Electric Double Breast Pumps | 12/21/2015 |
| K211755 | Zhejiang Carebao Co., Ltd. | Electric Breast Pump | 12/01/2021 |
| K222782 | Zhejiang Carebao Co., Ltd. | Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S) | 01/13/2023 |
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