Annelid
FDA 510(k) K940886 · Kinetic Concepts, Inc.
510(k) numberK940886
Submission
- Device name
- Annelid
- Applicant
- Kinetic Concepts, Inc.
San Antonio, TX, US - Received
- February 25, 1994
- Decision date
- November 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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|---|---|---|---|
| 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 |
More from Taiwan Biomaterial Co., Ltd.
| 510(k) | Device | Decision |
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| K050261 | V.A.C. Granufoam Silver Protection DressingOMP · Traditional | 05/26/2005SE |
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| K032310 | Mini V.A.C., V.A.C. Freedom, V.A.C. AtsOMP · Traditional | 10/10/2003SE |
| K022011 | V.A.C. Abdominal DressingFTL · Traditional | 02/26/2003SE |
| K021500 | Vacuum Assisted ClosureOMP · Traditional | 12/20/2002SE |
| K021501 | V.A.C. Instillamat (Vacuum Assisted Closure InstillamatOMP · Traditional | 12/02/2002SE |
| K020781 | Wet ChamberNAD · Traditional | 05/06/2002SE |
| K992448 | V.A.C. PlusOMP · Traditional | 01/18/2000SE |
| K972176 | Home Care Bead BedINX · Traditional | 01/16/1998SE |
| K972549 | SimpulseFNM · Traditional | 11/18/1997SE |
Questions and answers
When was Annelid cleared by the FDA?
Annelid (K940886) received a 510(k) decision of Substantially Equivalent on November 17, 1994, 265 days after the submission was received.
What is the product code of K940886?
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.