Product code JCX
- Device name
- Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4780
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250964 | Protable Phlegm Suction Unit (JMA D01) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2026-05-11 |
| K243638 | MV Flow Aspiration Pump (MVFLOWPMP01) | Microvention | 2025-06-13 |
| K251111 | Cary | Excitus AS | 2025-05-07 |
| K243418 | Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2024-12-02 |
| K233428 | Easycess Aspiration Pump | Guangzhou Easycess Medical Co.,Ltd | 2023-11-03 |
| K222552 | 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) | Stryker Instruments | 2022-12-09 |
| K182950 | Acare Suction Unit | Acare Technology Co., Ltd. | 2019-08-23 |
| K190789 | IntelliCartTM System | Dornoch Medical Systems | 2019-04-24 |
| K190105 | ZOOM Aspiration Pump | Taiwan Biomaterial Co., Ltd. | 2019-02-21 |
| K180115 | TWBM Pump | Taiwan Biomaterial Co., Ltd. | 2018-07-24 |
| K181398 | DV-300 Aspirator | Ding Hwa Co., Ltd. | 2018-07-23 |
| K172481 | IntelliCart System | Dornoch Medical Systems | 2017-09-14 |
| K161358 | Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds | Surgical Instrument Service and Savings, Inc. | 2017-08-03 |
| K162421 | IntelliCartTM System | Dornoch Medical Systems | 2016-12-21 |
| K153407 | Stryker Neptune 3 Waste Management System | Stryker Corporation | 2016-04-25 |
| K140809 | CLIQ DV-300 ASPIRATOR | Ding Hwa Co., Ltd. | 2014-06-23 |
| K140031 | SUCTION PUMP | Ding Hwa Co., Ltd. | 2014-04-28 |
| K133786 | DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID | Dornoch Medical Systems, Inc. | 2014-03-21 |
| K133196 | IMPACT MODEL 323 ASPIRATOR | Impact Instrumentation, Inc. | 2014-03-10 |
| K132308 | CLIQ DV-300 ASPIRATOR | Ding Hwa Co., Ltd. | 2013-12-30 |
| K132671 | STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM | Stryker Corporation | 2013-12-20 |
| K130001 | CARE SU01A SUCTION ASPIRATOR | Foshan Care Medical Technology Co., Ltd. | 2013-07-25 |
| K131099 | AG MASS | Hospitech Respiration , Ltd. | 2013-05-13 |
| K123188 | DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC | Dornoch Medical Systems, Inc. | 2013-03-04 |
| K122756 | PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING | Penumbra, Inc. | 2012-10-02 |
| K120065 | PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES | Plaxtron Industrial (M) Sdn. Bhd. | 2012-04-03 |
| K112421 | EMG SUCTION UNIT | Emg Technology Co., Ltd. | 2011-09-01 |
| K103535 | VACPLUS SUCTION UNIT | Apex Medical Corp. | 2011-02-24 |
| K102626 | VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01 | Vega Technologies, Inc. | 2010-11-12 |
| K090759 | BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM | Biodrain Medical, Inc. | 2009-04-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10612479280066 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2025-11-19 |
| 00763000981327 | Riptide Collection Canister with Intermediate Tubing | Micro Therapeutics, Inc. | 2025-10-31 |
| 00815067013609 | Roscoe Medical | Drive Devilbiss Healthcare | 2025-08-13 |
| 00092237626672 | Roscoe Medical | Drive Devilbiss Healthcare | 2025-02-10 |
| 00092237626627 | Roscoe Medical | Drive Devilbiss Healthcare | 2025-01-29 |
| 37613327644068 | Neptune | STRYKER CORPORATION | 2024-12-06 |
| 00050428550014 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2023-03-09 |
| 07613327562590 | Neptune | STRYKER CORPORATION | 2022-12-16 |
| 07613327563832 | Neptune | STRYKER CORPORATION | 2022-12-16 |
| 07613327576887 | Neptune | STRYKER CORPORATION | 2022-12-16 |
| 00092237622810 | Roscoe Medical | Drive Devilbiss Healthcare | 2021-04-05 |
| 00822383286563 | DRIVEMEDICAL | Drive Devilbiss Healthcare | 2019-06-21 |
| B245740000 | S-SCORT® lll | SSCOR, INC. | 2017-02-13 |
| 00092237603376 | Roscoe Medical | Drive Devilbiss Healthcare | 2016-10-07 |
| 00092237603383 | Roscoe Medical | Drive Devilbiss Healthcare | 2016-10-05 |
| 07613154688289 | Neptune 2 | STRYKER CORPORATION | 2016-09-23 |
| 07613327299342 | Neptune | STRYKER CORPORATION | 2016-09-23 |
| 07613327299335 | Neptune | STRYKER CORPORATION | 2016-09-23 |
| 07613327299311 | Neptune | STRYKER CORPORATION | 2016-09-23 |
| 07613327299298 | Neptune | STRYKER CORPORATION | 2016-09-23 |
| 07613327299281 | Neptune | STRYKER CORPORATION | 2016-09-23 |
| 07613327299274 | Neptune | STRYKER CORPORATION | 2016-09-23 |
| 07613327116656 | Neptune | STRYKER CORPORATION | 2016-09-23 |
| 07613154881963 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613154733224 | Neptune 2 | STRYKER CORPORATION | 2016-09-23 |
| 07613154688296 | Neptune 2 | STRYKER CORPORATION | 2016-09-23 |
| 07613154680849 | NA | STRYKER CORPORATION | 2016-09-23 |
| 00050428358689 | CVS/Pharmacy | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2016-09-20 |
| 00822383509136 | Drive | Drive Devilbiss Healthcare | 2016-09-16 |
| 00822383509143 | Drive | Drive Devilbiss Healthcare | 2016-09-16 |