Apparatus, Suction, Ward Use, Portable, Ac-Powered
FDA product code JCX · Class II (moderate risk) · 21 CFR 878.4780 · General, Plastic Surgery
77510(k) clearances
0PMA approvals
22recalls
Manufacturers
- Dornoch Medical Systems 6
- Impact Instrumentation, Inc. 5
- Ding Hwa Co., Ltd. 5
- Product & Educational Services 4
- Briox Technologies, Inc. 4
- Emg Technology Co., Ltd. 3
- Kinetic Concepts, Inc. 2
- Keymed (Medical & Industrial Equipment), Ltd. 2
- Taiwan Biomaterial Co., Ltd. 2
- Stryker Corporation 2
- Stirn Industries 2
- The Devilbiss Co. 1
- Cook Ob/Gyn 1
- Spiess Design, Inc. 1
- Acorn Group, Inc. 1
- Kolster Methods 1
- Morwel Corp. 1
- Northwest Orthopedics 1
- Cardio Surgical Concepts, Inc. 1
- Jiangsu Jumao X-Care Medical Equipment Co., Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250964 | Protable Phlegm Suction Unit (JMA D01)JCX · Traditional | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 05/11/2026SE |
| K243638 | MV Flow Aspiration Pump (MVFLOWPMP01)JCX · Traditional | Microvention | 06/13/2025SE |
| K251111 | CaryJCX · Traditional | Excitus AS | 05/07/2025SE |
| K243418 | Riptide Aspiration Pump; Riptide Collection Canister with Intermediate TubingJCX · Special | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 12/02/2024SE |
| K233428 | Easycess Aspiration PumpJCX · Traditional | Guangzhou Easycess Medical Co.,Ltd | 11/03/2023SE |
| K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen…JCX · Traditional | Stryker Instruments | 12/09/2022SE |
| K182950 | Acare Suction UnitJCX · Traditional | Acare Technology Co., Ltd. | 08/23/2019SE |
| K190789 | IntelliCartTM SystemJCX · Special | Dornoch Medical Systems | 04/24/2019SE |
| K190105 | ZOOM Aspiration PumpJCX · Special | Taiwan Biomaterial Co., Ltd. | 02/21/2019SE |
| K180115 | TWBM PumpJCX · Traditional | Taiwan Biomaterial Co., Ltd. | 07/24/2018SE |
| K181398 | DV-300 AspiratorJCX · Traditional | Ding Hwa Co., Ltd. | 07/23/2018SE |
| K172481 | IntelliCart SystemJCX · Special | Dornoch Medical Systems | 09/14/2017SE |
| K161358 | Medline ReNewal Reprocessed Stryker Neptune 2 ManifoldsJCX · Traditional | Surgical Instrument Service and Savings, Inc. | 08/03/2017SE |
| K162421 | IntelliCartTM SystemJCX · Special | Dornoch Medical Systems | 12/21/2016SE |
| K153407 | Stryker Neptune 3 Waste Management SystemJCX · Traditional | Stryker Corporation | 04/25/2016SE |
| K140809 | Cliq DV-300 AspiratorJCX · Traditional | Ding Hwa Co., Ltd. | 06/23/2014SE |
| K140031 | Suction PumpJCX · Traditional | Ding Hwa Co., Ltd. | 04/28/2014SE |
| K133786 | Dornoch Duo Suction Cart with: DL2800 Lid, CL500 Lid, Dornoch Quad Suction Cart with:…JCX · Traditional | Dornoch Medical Systems, Inc. | 03/21/2014SE |
| K133196 | Impact Model 323 AspiratorJCX · Traditional | Impact Instrumentation, Inc. | 03/10/2014SE |
| K132308 | Cliq DV-300 AspiratorJCX · Traditional | Ding Hwa Co., Ltd. | 12/30/2013SE |
| K132671 | Stryker Neptune 2 Waste Managment SystemJCX · Traditional | Stryker Corporation | 12/20/2013SE |
| K130001 | Care SU01A Suction AspiratorJCX · Traditional | Foshan Care Medical Technology Co., Ltd. | 07/25/2013SE |
| K131099 | AG MassJCX · Traditional | Hospitech Respiration , Ltd. | 05/13/2013SE |
| K123188 | Dornoch Duo Suction Cart with DL2800 Lid Model UL-DU2800, Dornoch Duo Suction Cart with…JCX · Special | Dornoch Medical Systems, Inc. | 03/04/2013SE |
| K122756 | Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max Canister/TubingJCX · Special | Penumbra, Inc. | 10/02/2012SE |
| K120065 | Plaxtron Suction Unit, Model 88AA51/88AA61 SeriesJCX · Traditional | Plaxtron Industrial (M) Sdn. Bhd. | 04/03/2012SE |
| K112421 | Emg Suction UnitJCX · Traditional | Emg Technology Co., Ltd. | 09/01/2011SE |
| K103535 | Vacplus Suction UnitJCX · Traditional | Apex Medical Corp. | 02/24/2011SE |
| K102626 | Vega Medical Suction Equipment, Model SU-01/SU-DC01JCX · Traditional | Vega Technologies, Inc. | 11/12/2010SE |
| K090759 | Biodrain Streamway Fluid Management SystemJCX · Traditional | Biodrain Medical, Inc. | 04/01/2009SE |
| K082762 | Aardvark Nasal Irrigation and Aspiration DeviceJCX · Traditional | Aardvark Medical | 11/12/2008SE |
| K080845 | Orwell Fluid Collection and Disposal SystemJCX · Traditional | Cardinalhealth | 04/30/2008SE |
| K081047 | Transposal Ultra SystemsJCX · Traditional | Dornoch Medical Systems, Inc. | 04/29/2008SE |
| K080005 | Sparmax Aspirator, Models TC-2000V ND VC-701JCX · Traditional | Ding Hwa Co., Ltd. | 04/24/2008SE |
| K063448 | Emg Ac/Dc Suction UnitJCX · Traditional | Emg Technology Co., Ltd. | 11/30/2006SE |
| K060277 | Boehringer Laboratories Suction Pump SystemJCX · Traditional | Boehringer Laboratories | 03/03/2006SE |
| K042349 | Emg Model SUA01 Suction UnitJCX · Abbreviated | Emg Technology Co., Ltd. | 12/16/2004SE |
| K011725 | Olympus Suction Pump, Model KV-5JCX · Traditional | Keymed (Medical & Industrial Equipment), Ltd. | 08/31/2001SE |
| K001716 | Redon SetJCX · Traditional | Pfm Produkte Fur Die Medizin AG | 07/19/2000SE |
| K982304 | Devilbiss Suction UnitJCX · Traditional | Sunrise Medical Hhg, Inc. | 09/25/1998SE |
| K974038 | The Aspirator, 6FT Silicone Tubing, Metal Tubing Adapter, Glass Reservoir, Neoprene…JCX · Traditional | A & A Medical, Inc. | 05/11/1998SE |
| K963558 | Cpi Model 6260, 6260A or 6261 Oil-Less AspiratorJCX · Traditional | Contemporary Products, Inc. | 12/04/1996SE |
| K950698 | Lsu 2000 Portable Suction UnitJCX · Traditional | Laerdal Medical Corp. | 05/09/1995SE |
| K945062 | VacplusJCX · Traditional | Kinetic Concepts, Inc. | 03/14/1995SE |
| K944119 | Sure-Flo Irrigation Y Tubing SetJCX · Traditional | O.R. Resources, Inc. | 12/05/1994SE |
| K940886 | AnnelidJCX · Traditional | Kinetic Concepts, Inc. | 11/17/1994SE |
| K941527 | Model 2300 General Purpose Suction PumpJCX · Traditional | Product & Educational Services | 05/18/1994SE |
| K941526 | Model 2000 Mild Intermittent Suction PumpJCX · Traditional | Product & Educational Services | 05/18/1994SE |
| K941525 | Model 2200 Thoracic Suction PumpJCX · Traditional | Product & Educational Services | 05/18/1994SE |
| K941524 | Model 2100 Mild Intermittent Suction PumpJCX · Traditional | Product & Educational Services | 05/17/1994SE |
| K935218 | Schuco-Vac Model 178JCX · Traditional | Schuco, Inc. | 04/05/1994SE |
| K930852 | Olympus Suction Pump Model KV-4JCX · Traditional | Keymed (Medical & Industrial Equipment), Ltd. | 03/31/1994SE |
| K930030 | Suction Tubes: House, BaronJCX · Traditional | Thomasville Medical Assoc. | 02/25/1994SE |
| K930900 | Cook Aspiration UnitJCX · Traditional | Cook Ob/Gyn | 07/22/1993SE |
| K920288 | Powered Vacuum Aspirator 1110-G-062JCX · Traditional | Stirn Industries | 06/29/1992SE |
| K920287 | Powered Vacuum Aspirator 1110-G-030JCX · Traditional | Stirn Industries | 06/29/1992SE |
| K914694 | Sterile View(Tm) Hi Effic Helmet/Back PK Sup/ExhauJCX · Traditional | Depuy, Inc. | 01/16/1992SE |
| K914177 | HydrodisectorJCX · Traditional | Spiess Design, Inc. | 11/29/1991SE |
| K900430 | Irrigation and Suction ApparatusJCX · Traditional | Acorn Group, Inc. | 06/05/1990SE |
| K895761 | General AsperatorJCX · Traditional | Kolster Methods | 10/18/1989SE |
| K872094 | Vacu-AideJCX · Traditional | The Devilbiss Co. | 10/15/1987SE |
| K843081 | Tugs-Transportable Univ. Gradient SuctJCX · Traditional | Creative Medical Laboratories, Inc. | 10/11/1984SE |
| K842050 | Impact Model 316JCX · Traditional | Impact Instrumentation, Inc. | 08/03/1984SE |
| K841538 | Impact Model 308JCX · Traditional | Impact Instrumentation, Inc. | 06/11/1984SE |
| K841160 | Morwel AspiratorJCX · Traditional | Morwel Corp. | 05/31/1984SE |
| K832301 | Direct Bonded Bracket RemoverJCX · Traditional | Northwest Orthopedics | 08/31/1983SE |
| K820331 | Impact, Model 302JCX · Traditional | Impact Instrumentation, Inc. | 02/23/1982SE |
| K820330 | Impact, Model E-12JCX · Traditional | Impact Instrumentation, Inc. | 02/23/1982SE |
| K801349 | Loseff Balloon Type Self-Retention WoundJCX · Traditional | Loseff Medical Designers, Ltd. | 08/07/1980SE |
| K801043 | E-Vax Chest Drainage SystemJCX · Traditional | Cardio Surgical Concepts, Inc. | 06/20/1980SE |
| K792592 | Ambu Universal Suction PumpJCX · Traditional | Narco Air-Shields | 01/11/1980SE |
| K791241 | Briox Model 2000-CA Compressor UnitJCX · Traditional | Briox Technologies, Inc. | 07/24/1979SE |
| K791240 | Briox Model 2000-C Compressor UnitJCX · Traditional | Briox Technologies, Inc. | 07/24/1979SE |
| K791239 | Briox Model 2000-A Aspirator UnitJCX · Traditional | Briox Technologies, Inc. | 07/24/1979SE |
| K791238 | Briox Model 2000-CQ Quiet CompressorJCX · Traditional | Briox Technologies, Inc. | 07/24/1979SE |
| K791210 | Portable AspiratorJCX · Traditional | Sam Say Assoc. | 07/24/1979SE |
| K771071 | Porto-VacJCX · Traditional | Cpac, Inc. | 07/14/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2282-2026 Class II | Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune…It has been identified that the impacted docking station (SN 2521008873) was not product released from… | Stryker Corporation | 05/06/2026Open, Classified |
| Z-1341-2026 Class II | Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA…units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for… | Laerdal Medical Corporation | 01/13/2026Open, Classified |
| Z-0868-2021 Class II | Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052…Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction… | Laerdal Medical (Suzhou) Co., Ltd. | 12/18/2020Terminated |
| Z-0973-2018 Class II | LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered…A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was… | Laerdal Medical Corporation | 08/31/2017Terminated |
| Z-1873-2017 Class II | Laerdal Compact Suction Unit 4 under the following labels: 1) 300 ml (3.3 lbs) canister…The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged. | Laerdal Medical Corporation | 01/08/2017Terminated |
| Z-2630-2016 Class II | 120 V Neptune 3 Rover, Model Number: 0703-001-000Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the… | Stryker Instruments Div. of Stryker… | 07/01/2016Terminated |
| Z-2246-2016 Class II | DeVilbiss Model 7305P-D Powered Suction UnitA small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during… | DeVilbiss Healthcare LLC | 05/23/2016Terminated |
| Z-2151-2015 Class II | THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical…Vacuum pump may not perform to specification. | Gardner Denver Thomas Inc | 06/04/2015Terminated |
| Z-2150-2015 Class II | THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242 Product Usage: medical…Vacuum pump may not perform to specification. | Gardner Denver Thomas Inc | 06/04/2015Terminated |
| Z-2149-2015 Class II | THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage: medical…Vacuum pump may not perform to specification. | Gardner Denver Thomas Inc | 06/04/2015Terminated |
| Z-2099-2015 Class II | 0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V)…Stryker Instruments is initiating a recall of the Neptune 2 Waste Management System due to complaints… | Stryker Instruments Div. of Stryker… | 05/22/2015Terminated |
| Z-2642-2014 Class II | Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction…suction canister lids may have occluded ports. | EMG Technology Co., Ltd. | 08/03/2014Terminated |
| Z-0903-2014 Class II | Neptune 2 Rover Ultra Waste Management SystemThe purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the… | Stryker Instruments Div. of Stryker… | 12/30/2013Terminated |
| Z-0902-2014 Class II | Neptune 2 Rover Ultra Waste Management System.The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the… | Stryker Instruments Div. of Stryker… | 12/30/2013Terminated |
| Z-2212-2013 Class II | Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and…Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste… | Zeppessis Reprocessing, LLC | 08/16/2013Terminated |
| Z-2319-2013 Class II | DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP…End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to… | DeVilbiss Healthcare LLC | 03/07/2013Terminated |
| Z-2430-2012 Class III | Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance…A shipment mix-up took place. | Impact Instrumentation, Inc. | 03/30/2012Terminated |
| Z-0455-2013 Class II | Neptune 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult…Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new… | Stryker Instruments Div. of Stryker… | 05/24/2011Terminated |
| Z-0454-2013 Class II | Neptune 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult…Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new… | Stryker Instruments Div. of Stryker… | 05/24/2011Terminated |
| Z-0863-2009 | DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or…Improper suction: Regulator knob does not turn properly which can affect the suction level. | Sunrise Medical | 10/27/2008Terminated |
| Z-2440-2008 | 500 mL InfoV.A.C. Canister (without Gel); Part #M8275071/5 (5 canister pack) and Part…The port on the 500mL InfoV.A.C. Canister that connects to the suction pump tubing was found to be partially… | KCI USA, Inc. | 07/29/2008Terminated |
| Z-2439-2008 | 500 mL InfoV.A.C. Canisters (with Gel); Part #M8275063/5 (5 canister pack) and Part…The port on the 500mL InfoV.A.C. Canister that connects to the suction pump tubing was found to be partially… | KCI USA, Inc. | 07/29/2008Terminated |