Protable Phlegm Suction Unit (JMA D01)
FDA 510(k) K250964 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
510(k) numberK250964
Submission
- Device name
- Protable Phlegm Suction Unit (JMA D01)
- Applicant
- Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
Danyang, CN - Received
- March 31, 2025
- Decision date
- May 11, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K243638 | MV Flow Aspiration Pump (MVFLOWPMP01)JCX · Traditional | Microvention | 06/13/2025SE |
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| 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 |
More from Ding Hwa Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253632 | Manual Wheelchair (W50)IOR · Traditional | 01/29/2026SE |
| K252828 | Manual Wheelchair (W47)IOR · Traditional | 12/05/2025SE |
| K252825 | Manual Wheelchair (W45)IOR · Traditional | 12/05/2025SE |
| K251130 | Portable Oxygen Concentrator (JM-P50A)CAW · Traditional | 08/21/2025SE |
| K232783 | Power wheelchair (Model: JMPW-01W)ITI · Traditional | 01/19/2024SE |
| K230969 | Oxygen ConcentratorCAW · Traditional | 11/09/2023SE |
| K200466 | Manual Wheelchair (Model W28)IOR · Traditional | 06/14/2021SE |
Questions and answers
When was Protable Phlegm Suction Unit (JMA D01) cleared by the FDA?
Protable Phlegm Suction Unit (JMA D01) (K250964) received a 510(k) decision of Substantially Equivalent on May 11, 2026, 406 days after the submission was received.
What is the product code of K250964?
The FDA product code is JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 878.4780.