Care-E-Vac 3
FDA 510(k) K062610 · Ohio Medical Corporation
510(k) numberK062610
Submission
- Device name
- Care-E-Vac 3
- Applicant
- Ohio Medical Corporation
Gurnee, IL, US - Received
- September 5, 2006
- Decision date
- September 28, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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| K260892 | Suction Pump (SU-90)BTA · Traditional | Shenzhen HugeMed Medical Technical Development… | 05/14/2026SE |
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| K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)BTA · Traditional | Shenzhen Desida Technology Co., Ltd. | 05/16/2025SE |
| K251101 | AIRO Suction Unit (AIRO-01)BTA · Traditional | Cro, LLC | 04/26/2025SE |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 04/23/2025SE |
More from Shenzhen Kingboom Technology Co., Ltd.
| 510(k) | Device | Decision |
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| K081185 | Moblvac W.C.BTA · Special | 05/02/2008SE |
Questions and answers
When was Care-E-Vac 3 cleared by the FDA?
Care-E-Vac 3 (K062610) received a 510(k) decision of Substantially Equivalent on September 28, 2006, 23 days after the submission was received.
What is the product code of K062610?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.