FDA 510(k) Applications for Medical Device Product Code "JCX"
(Apparatus, Suction, Ward Use, Portable, Ac-Powered)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K974038 | A & A MEDICAL, INC. | THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT | 05/11/1998 |
| K082762 | AARDVARK MEDICAL | AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE | 11/12/2008 |
| K182950 | Acare Technology Co., Ltd. | Acare Suction Unit | 08/23/2019 |
| K103535 | APEX MEDICAL CORP. | VACPLUS SUCTION UNIT | 02/24/2011 |
| K090759 | BIODRAIN MEDICAL, INC. | BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM | 04/01/2009 |
| K060277 | BOEHRINGER LABORATORIES | BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM | 03/03/2006 |
| K080845 | Cardinal Health | ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM | 04/30/2008 |
| K963558 | CONTEMPORARY PRODUCTS, INC. | CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR | 12/04/1996 |
| K140031 | DING HWA CO., LTD | SUCTION PUMP | 04/28/2014 |
| K132308 | DING HWA CO., LTD. | CLIQ DV-300 ASPIRATOR | 12/30/2013 |
| K140809 | DING HWA CO., LTD. | CLIQ DV-300 ASPIRATOR | 06/23/2014 |
| K181398 | Ding Hwa Co., Ltd. | DV-300 Aspirator | 07/23/2018 |
| K080005 | DING HWA CO., LTD. | SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701 | 04/24/2008 |
| K172481 | Dornoch Medical Systems | IntelliCart System | 09/14/2017 |
| K190789 | Dornoch Medical Systems | IntelliCartTM System | 04/24/2019 |
| K162421 | DORNOCH MEDICAL SYSTEMS | IntelliCartTM System | 12/21/2016 |
| K123188 | DORNOCH MEDICAL SYSTEMS, INC. | DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC | 03/04/2013 |
| K133786 | DORNOCH MEDICAL SYSTEMS, INC. | DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID | 03/21/2014 |
| K081047 | DORNOCH MEDICAL SYSTEMS, INC. | TRANSPOSAL ULTRA SYSTEMS | 04/29/2008 |
| K063448 | EMG TECHNOLOGY CO., LTD. | EMG AC/DC SUCTION UNIT | 11/30/2006 |
| K042349 | EMG TECHNOLOGY CO., LTD. | EMG MODEL SUA01 SUCTION UNIT | 12/16/2004 |
| K112421 | EMG TECHNOLOGY CO., LTD. | EMG SUCTION UNIT | 09/01/2011 |
| K130001 | FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. | CARE SU01A SUCTION ASPIRATOR | 07/25/2013 |
| K131099 | HOSPITECH RESPIRATION LTD. | AG MASS | 05/13/2013 |
| K133196 | IMPACT INSTRUMENTATION, INC. | IMPACT MODEL 323 ASPIRATOR | 03/10/2014 |
| K011725 | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. | OLYMPUS SUCTION PUMP, MODEL KV-5 | 08/31/2001 |
| K122756 | PENUMBRA, INC. | PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING | 10/02/2012 |
| K001716 | PFM PRODUKTE FUR DIE MEDIZIN AG | REDON SET | 07/19/2000 |
| K120065 | PLAXTRON INDUSTRIAL (M) SDN. BHD. | PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES | 04/03/2012 |
| K132671 | STRYKER CORPORATION | STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM | 12/20/2013 |
| K153407 | STRYKER CORPORATION | Stryker Neptune 3 Waste Management System | 04/25/2016 |
| K222552 | Stryker Instruments | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) | 12/09/2022 |
| K982304 | SUNRISE MEDICAL HHG, INC. | DEVILBISS SUCTION UNIT | 09/25/1998 |
| K161358 | SURGICAL INSTRUMENT SERVICE AND SAVINGS INC | Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds | 08/03/2017 |
| K180115 | Taiwan Biomaterial Co., Ltd. | TWBM Pump | 07/24/2018 |
| K190105 | Taiwan Biomaterial Co., Ltd. | ZOOM Aspiration Pump | 02/21/2019 |
| K102626 | VEGA TECHNOLOGIES, INC. | VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01 | 11/12/2010 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
