JCX · Apparatus, Suction, Ward Use, Portable, Ac-Powered
General, Plastic Surgery · 21 CFR 878.4780 · Class 2
Overview
| Product Code | JCX |
|---|---|
| Device Name | Apparatus, Suction, Ward Use, Portable, Ac-Powered |
| Regulation | 21 CFR 878.4780 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 76)
Showing 20 most recent of 76 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243638 | MV Flow Aspiration Pump (MVFLOWPMP01) | Microvention | Jun 13, 2025 | SESE |
| K251111 | Cary | Excitus AS | May 7, 2025 | SESE |
| K243418 | Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | Dec 2, 2024 | SESE |
| K233428 | Easycess Aspiration Pump | Guangzhou Easycess Medical Co.,Ltd | Nov 3, 2023 | SESE |
| 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 | Dec 9, 2022 | SESE |
| K182950 | Acare Suction Unit | Acare Technology Co., Ltd. | Aug 23, 2019 | SESE |
| K190789 | IntelliCartTM System | Dornoch Medical Systems | Apr 24, 2019 | SESE |
| K190105 | ZOOM Aspiration Pump | Taiwan Biomaterial Co., Ltd. | Feb 21, 2019 | SESE |
| K180115 | TWBM Pump | Taiwan Biomaterial Co., Ltd. | Jul 24, 2018 | SESE |
| K181398 | DV-300 Aspirator | Ding Hwa Co., Ltd. | Jul 23, 2018 | SESE |
| K172481 | IntelliCart System | Dornoch Medical Systems | Sep 14, 2017 | SESE |
| K161358 | Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds | Surgical Instrument Service and Savings, Inc. | Aug 3, 2017 | SESE |
| K162421 | IntelliCartTM System | Dornoch Medical Systems | Dec 21, 2016 | SESE |
| K153407 | Stryker Neptune 3 Waste Management System | Stryker Corporation | Apr 25, 2016 | SESE |
| K140809 | CLIQ DV-300 ASPIRATOR | Ding Hwa Co., Ltd. | Jun 23, 2014 | SESE |
| K140031 | SUCTION PUMP | Ding Hwa Co., Ltd. | Apr 28, 2014 | SESE |
| K133786 | DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID | Dornoch Medical Systems, Inc. | Mar 21, 2014 | SESE |
| K133196 | IMPACT MODEL 323 ASPIRATOR | Impact Instrumentation, Inc. | Mar 10, 2014 | SESE |
| K132308 | CLIQ DV-300 ASPIRATOR | Ding Hwa Co., Ltd. | Dec 30, 2013 | SESE |
| K132671 | STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM | Stryker Corporation | Dec 20, 2013 | SESE |
Top Applicants
- Impact Instrumentation, Inc. — 5 clearances
- Ding Hwa Co., Ltd. — 5 clearances
- Product & Educational Services — 4 clearances
- Briox Technologies, Inc. — 4 clearances
- Emg Technology Co., Ltd. — 3 clearances
