FDA 510(k) Applications for Medical Device Product Code "BTA"
(Pump, Portable, Aspiration (Manual Or Powered))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K971107 | ALEXANDER MFG. CO. | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5 | 06/05/1997 |
| K201203 | Anest Iwata Sparmax Co., Ltd. | Cliq Aspirator | 09/03/2020 |
| K232831 | Anoxia Medical Inc. | Quiver Aspiration Pump | 02/22/2024 |
| K122619 | APPLIED MEDICAL | EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET | 10/02/2012 |
| K011601 | ARDO MEDICAL AG | ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX | 06/08/2001 |
| K223373 | Aroa Biosurgery Ltd. | EnivoÖ | 04/07/2023 |
| K153459 | ATHENA GTX | TACVAC | 01/28/2016 |
| K090445 | ATMOS INC. | ATMOS C361/C451 SUCTION PUMP | 02/27/2009 |
| K103042 | ATMOS INC. | ATMOS E 201 THORAX AND ATMOS S 201 THORAX | 04/15/2011 |
| K241799 | ATMOS MedizinTechnik GmbH & Co. KG | ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system wit | 03/07/2025 |
| K130131 | ATRIUM MEDICAL CORP. | EDRAIN CHEST DRAINAGE SYSTEM | 02/28/2013 |
| K090379 | AVITA CORPORATION | AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES | 05/26/2010 |
| K241852 | AViTA Corporation | Nasal Aspirator (NS 13) | 12/31/2024 |
| K980392 | BYRON MEDICAL | PSI-TEC ASPIRATOR | 03/05/1998 |
| K181667 | Centese, Inc. | Thoraguard System | 11/29/2018 |
| K161002 | COOK INCORPORATED | Aprima Smartesis Centesis Pump | 09/28/2016 |
| K251101 | CRO, LLC | AIRO Suction Unit (AIRO-01) | 04/26/2025 |
| K242028 | Dongguanshi Yiyingmei Technology Co., Ltd. | Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) | 11/19/2024 |
| K221676 | DRW Medical | Exsalta | 09/16/2022 |
| K013116 | EVER-SAFETY TECHNICAL SERVICE | DURQ/ QUALIDURA | 01/18/2002 |
| K080745 | GENADYNE BIOTECHNOLOGIES, INC. | GENADYNE A4 POWERED SUCTION PUMP | 07/30/2008 |
| K243138 | Geon Corporation | Geon (S2) Nasal Aspirator | 02/04/2025 |
| K220126 | Geon Corporation | Geonic Nasal Aspirator, Geonic Nasal Cleaner | 02/02/2023 |
| K970186 | GI SUPPLY | GI SUPPLY PARACENTESIS PUMP | 02/14/1997 |
| K221042 | GI Supply, Inc. | Renova RP Centesis Pump | 04/19/2023 |
| K052626 | HAEMONETICS CORP. | SMARTSUCTION HARMONY DEVICE | 10/05/2005 |
| K062801 | HAEMONETICS CORP. | SMARTSUCTION SOLO DEVICE | 10/04/2006 |
| K093241 | HERSILL, S.L. | V7 PORTABLE SUCTION UNITS | 04/27/2010 |
| K241202 | Hetaida Technology Co., Ltd. | Electric nasal aspirator (HTD2601US) | 07/01/2024 |
| K960492 | I.C. MEDICAL, INC. | SI CONTROLLER MODEL SI 500 | 12/23/1996 |
| K041405 | INDUSTRIAL & MEDICAL DESIGN, INC. | ASPIRATION PUMP, MODEL IMD-020 | 09/02/2004 |
| K981703 | KARL STORZ ENDOSCOPY | KSEA UNIMAT 45 | 08/12/1998 |
| K993668 | LAERDAL MEDICAL A/S | LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 | 12/20/1999 |
| K980454 | LYSONIX, INC. | LYSONIX ASPIRATION PUMP | 03/18/1998 |
| K092903 | MAQUET GMBH AND CO. KG | BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING | 12/01/2009 |
| K982371 | MEDCO MFG. | MEDCO ASPIRATOR IV | 02/12/1999 |
| K130123 | MEDELA AG | BASIC AND DOMINANT FLEX SUCTION PUMPS | 10/11/2013 |
| K021368 | MEDELA AG | MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 | 05/15/2002 |
| K033179 | MEDELA AG | MEDELA CLARIO HOME CARE PUMP | 10/15/2003 |
| K043544 | MEDELA AG | MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR | 01/07/2005 |
| K130210 | MEDELA AG | MEDELA THOPAZ | 03/15/2013 |
| K080212 | MEDELA AG | MEDELA THOPAZ, MODEL 200 0288 | 07/23/2008 |
| K141553 | MEDELA AG | MEDELA THOPAZ+ | 08/25/2014 |
| K061205 | MEDELA AG | MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR | 06/21/2006 |
| K153663 | MEDELA AG | Vario 8/18/ci | 05/18/2016 |
| K983552 | MEDELA, INC. | BASIC, MEDIAN, DOMINANT, AND VARIO | 01/07/1999 |
| K963775 | MEDICAL SPECIFICS, INC. | MODEL 8800 ASPIRATOR | 03/26/1997 |
| K203135 | Medline Industries, Inc. | Medline Vacu-line Suction Aspirator | 05/04/2021 |
| K052650 | MERITS HEALTH PRODUCTS CO., LTD. | PIONEER U601 SERIES ASPIRATOR | 11/04/2005 |
| K973268 | MICROAIRE SURGICAL INSTRUMENTS, INC. | MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM | 11/26/1997 |
| K040239 | NEOMEDIX CORP. | SUPRAFLOW CONSOLE | 02/17/2004 |
| K042943 | NOUVAG AG | NOUVAG AG - VACUSON 40 AND VACUSON 60 | 12/17/2004 |
| K061133 | NOVASPINE LLC | SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S | 07/11/2006 |
| K062610 | OHIO MEDICAL CORPORATION | CARE-E-VAC 3 | 09/28/2006 |
| K081185 | OHIO MEDICAL CORPORATION | MOBLVAC W.C. | 05/02/2008 |
| K051758 | PENUMBRA, INC. | PENUMBRA ASPIRATION PUMP, MODEL 115V | 08/17/2005 |
| K140179 | PRECISION MEDICAL, INC. | EASY GO VAC | 04/25/2014 |
| K971749 | PRECISION MEDICAL, INC. | EASYGO ASPIRATOR | 04/01/1998 |
| K173389 | Rex Medical, L.P. | Rex Medical Aspiration Pump | 01/30/2018 |
| K980301 | SERVIZI MEDICO ESTETICI ITALINAI SRL. | IP-16 | 03/24/1998 |
| K013585 | SERVOX MEDIZINTECHNIK GMBH | MEDIPORT 2000 MOBILE | 01/28/2002 |
| K251450 | Shenzhen Desida Technology Co., Ltd. | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009) | 06/06/2025 |
| K233901 | Shenzhen Desida Technology Co., Ltd. | Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) | 03/20/2024 |
| K244033 | Shenzhen Desida Technology Co., Ltd. | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) | 05/16/2025 |
| K250697 | Shenzhen Kingboom Technology Co., Ltd | Electric Nasal Aspirator (BC026, BC025, BC023) | 04/23/2025 |
| K222547 | Shenzhen XinLianFeng Technology CO.,LTD | Electric nasal aspirator | 10/20/2022 |
| K141255 | SIMEX MEDIZINTECHNIK GMBH | SIMEX SUBGLOTTIC ASPIRATION SYSTEM | 09/22/2014 |
| K222856 | SOMAVAC Medical Solutions, Inc. | SOMAVAC 100 Sustained Vacuum System | 10/19/2022 |
| K180606 | SOMAVAC Medical Solutions, Inc. | SOMAVAC Device | 05/31/2018 |
| K231063 | SOMAVAC Medical Solutions, Inc. | SOMAVAC« 100 Sustained Vacuum System | 05/12/2023 |
| K992026 | SORING GMBH MEDIZINTECHNIK | SORING GMBH, SONOCA 300 | 09/23/1999 |
| K964997 | SSCOR | S-SCORT (2500) | 03/05/1997 |
| K041154 | SSCOR | S-SCORT...JR QUICKDRAW, MODEL 2400 | 05/18/2004 |
| K981602 | SUNRISE MEDICAL HHG, INC. | DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR | 07/17/1998 |
| K180863 | TaiDoc Technology Corporation | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator | 12/19/2018 |
| K965059 | THOMAS INDUSTRIES | CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243) | 03/04/1997 |
| K041199 | THOMAS INDUSTRIES | MEDI-PUMP ASPIRATOR, MODEL 1615 | 06/01/2004 |
| K984363 | XOMED, INC. | XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM | 02/26/1999 |
| K071607 | ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. | ASA01 HEAVY DUTY SUCTION PUMP | 06/26/2007 |
| K170533 | ZOLL Medical Corporation | Model 330 Multifunction Aspirator | 04/18/2017 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
