# Somavac Medical Solutions, Inc.

- Location (FDA's records): Bartlett, TN
- FDA decisions: 3 (2018–2023): 3 510(k) clearances
- Product codes: BTA (3)
- 510(k) review time since 2016: median 28 days, against 125 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Precision Medical, Inc.: 1 (https://510kreport.com/company/precision-medical)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)

## Firms that cite its devices most
- Aroa Biosurgery, Ltd.: 1 (https://510kreport.com/company/aroa-biosurgery)

## Its most-cited devices
- K222856: SOMAVAC 100 Sustained Vacuum System (2022), cited by 2
- K180606: SOMAVAC Device (2018), cited by 1

## Recent decisions
- K231063: SOMAVAC® 100 Sustained Vacuum System (May 12, 2023)
- K222856: SOMAVAC 100 Sustained Vacuum System (Oct 19, 2022)
- K180606: SOMAVAC Device (May 31, 2018)

Source page: https://510kreport.com/company/somavac-medical-solutions