SOMAVAC 100 Sustained Vacuum System
FDA 510(k) K222856 · Somavac Medical Solutions, Inc.
510(k) numberK222856
Submission
- Device name
- SOMAVAC 100 Sustained Vacuum System
- Applicant
- Somavac Medical Solutions, Inc.
Bartlett, TN, US - Received
- September 21, 2022
- Decision date
- October 19, 2022
- 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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| 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.
Questions and answers
When was SOMAVAC 100 Sustained Vacuum System cleared by the FDA?
SOMAVAC 100 Sustained Vacuum System (K222856) received a 510(k) decision of Substantially Equivalent on October 19, 2022, 28 days after the submission was received.
What is the product code of K222856?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.