Olympus Suction Pump, Model KV-5
FDA 510(k) K011725 · Keymed (Medical & Industrial Equipment), Ltd.
510(k) numberK011725
Submission
- Device name
- Olympus Suction Pump, Model KV-5
- Applicant
- Keymed (Medical & Industrial Equipment), Ltd.
Southend-On-Sea, Essex, GB - Received
- June 4, 2001
- Decision date
- August 31, 2001
- 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 |
|---|---|---|
| K100899 | Olympus Endoscopic Flushing Pump, Model OPF-2FEQ · Traditional | 09/13/2010SE |
| K000948 | Olympus Endoscopic Flushing Pump Model OFP-1FEQ · Traditional | 05/12/2000SE |
| K962528 | Olympus Mobile Chair/CouchFZK · Traditional | 12/12/1996SE |
| K930852 | Olympus Suction Pump Model KV-4JCX · Traditional | 03/31/1994SE |
| K881478 | Modified Keymed Flexible Esophageal DilatorsKNQ · Traditional | 09/14/1988SE |
Questions and answers
When was Olympus Suction Pump, Model KV-5 cleared by the FDA?
Olympus Suction Pump, Model KV-5 (K011725) received a 510(k) decision of Substantially Equivalent on August 31, 2001, 88 days after the submission was received.
What is the product code of K011725?
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.