# K231063: SOMAVAC® 100 Sustained Vacuum System

- Pathway: 510(k) (Special)
- Applicant: Somavac Medical Solutions, Inc.
- Decided: May 12, 2023 after 28 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or Powered))
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K883582 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222856: SOMAVAC 100 Sustained Vacuum System, Somavac Medical Solutions, Inc. (2022) Summary page 4.

## Indications for use
The SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) is a portable battery powered vacuum source / waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for use in homecare and healthcare environments.

Source page: https://510kreport.com/device/K231063
Methodology: https://510kreport.com/methodology