Panels › General, Plastic Surgery › Product code JCX · Class 2
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Regulation 878.4780
1510(k)s in 12 months (77 all time)
2recalls in 12 months (24 all time)
20recalls that name a 510(k)
Top companies in JCX
| Company | 510(k)s | Recalls |
|---|---|---|
| Dornoch Medical Systems | 6 | 0 |
| Impact Instrumentation, Inc. | 5 | 1 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 6 |
| Ding Hwa Co., Ltd. | 5 | 0 |
| Briox Technologies, Inc. | 4 | 0 |
| Emg Technology Co., Ltd. | 3 | 1 |
| Kinetic Concepts, Inc. | 2 | 2 |
| Laerdal Medical Corp. | 1 | 3 |
| Product & Educational Services | 4 | 0 |
| Gardner Denver Thomas Inc | 0 | 3 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2026 | Stryker Corporation Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System Open, Classified |
JCX | K132671 |
| Feb 11, 2026 | Laerdal Medical Corporation Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA)
1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052;
2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062;
3) LCSU 4, RTCA; Catalog Number: 881152; Open, Classified |
JCX | K120065 |
| Dec 18, 2020 | Laerdal Medical (Suzhou) Co., Ltd. Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers
880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit f Terminated |
JCX | K120065 |
| Aug 31, 2017 | Laerdal Medical Corporation LCSU 4, Laerdal Compact Suction Unit
The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove Terminated |
JCX | K120065 |
| Jan 8, 2017 | Laerdal Medical Corporation Laerdal Compact Suction Unit 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit ( Terminated |
JCX | None listed |
| Aug 23, 2016 | Stryker Instruments Div. of Stryker Corporation 120 V Neptune 3 Rover, Model Number: 0703-001-000 Terminated |
JCX | K153407 |
| Jul 20, 2016 | DeVilbiss Healthcare LLC DeVilbiss Model 7305P-D Powered Suction Unit Terminated |
JCX | K982304 |
| Jul 20, 2015 | Gardner Denver Thomas Inc THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243
Product Usage:
medical aspirator Terminated |
JCX | K965059 |
| Jul 20, 2015 | Gardner Denver Thomas Inc THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242
Product Usage:
medical aspirator Terminated |
JCX | K965059 |
| Jul 20, 2015 | Gardner Denver Thomas Inc THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240
Product Usage:
medical aspirator Terminated |
JCX | K965059 |
| Jul 17, 2015 | Stryker Instruments Div. of Stryker Corporation 0702-001-350Q, Diverter Valve Assembly
0702-001-000, Neptune 2 Rover Ultra (120V)
0702-001-000R, Repair Neptune 2 Rover
0702-002-000, Neptune 2 Rover Ultra (230V)
0702-002-000ES, Neptune 2 Rover (230 Terminated |
JCX | K132671 |
| Sep 13, 2014 | EMG Technology Co., Ltd. Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister).
The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The Terminated |
JCX | K042349 |
| Jan 31, 2014 | Stryker Instruments Div. of Stryker Corporation Neptune 2 Rover Ultra Waste Management System Terminated |
JCX | K132671 |
| Jan 31, 2014 | Stryker Instruments Div. of Stryker Corporation Neptune 2 Rover Ultra Waste Management System. Terminated |
JCX | K132671 |
| Oct 1, 2013 | DeVilbiss Healthcare LLC DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing Terminated |
JCX | K982304 |
| Sep 17, 2013 | Zeppessis Reprocessing, LLC Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems:
The Neptune Waste management system is intended to be used in the Operating Roo Terminated |
JCX | None listed |
| Dec 3, 2012 | Stryker Instruments Div. of Stryker Corporation Neptune 2 Rover - ULTRA ~230V ~ 50 Hz 12A
REF 0702-002-000, Rx Caution, consult accompanying documents
Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg,
The Neptune Waste Management S Terminated |
JCX | None listed |
| Dec 3, 2012 | Stryker Instruments Div. of Stryker Corporation Neptune 2 Rover - ULTRA ~120V ~ 60 Hz 12A
REF 0702-001-000, Rx, Caution, consult accompanying documents
Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg,
The Neptune Waste Management S Terminated |
JCX | None listed |
| Sep 20, 2012 | Impact Instrumentation, Inc. Model 324JL On-Board Suction System
Intended use: On-board suction system for Ambulance manufacturers. Terminated |
JCX | K820331 |
| Feb 10, 2009 | Sunrise Medical DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. The device may include a microbial filter. Terminated |
JCX | K982304 |
| Sep 20, 2008 | KCI USA, Inc. 500 mL InfoV.A.C. Canister (without Gel); Part #M8275071/5 (5 canister pack) and Part #M8275071/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, Terminated |
JCX | K063740 |
| Sep 20, 2008 | KCI USA, Inc. 500 mL InfoV.A.C. Canisters (with Gel); Part #M8275063/5 (5 canister pack) and Part #M8275063/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, In Terminated |
JCX | K063740 |
| Jan 11, 2006 | Kinetic Concepts, Inc V.A.C. ATS Canister with Gel (500 mL), Part #M6275063/10.S, distributed by Kinetic Concepts, Inc., San Antonio, TX. Product is labeled as STERILE. Terminated |
JCX | K032310 |
| Oct 22, 2004 | Kinetic Concepts, Inc V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230 Terminated |
JCX | K032310 |
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