# K180606: SOMAVAC Device

- Pathway: 510(k) (Traditional)
- Applicant: Somavac Medical Solutions, Inc.
- Decided: May 31, 2018 after 85 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: 2 generations back to K883582 (1988). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140179: Easy GO Vac, Precision Medical, Inc. (2014) Summary page 4.
- K972703: Redyrob-Closed Wound Drainage System, B.Braun Medical, Inc. (1997) Summary page 4.

## Most influential descendants
- K222856: SOMAVAC 100 Sustained Vacuum System (2022), 2 descendants of its own
- K231063: SOMAVAC® 100 Sustained Vacuum System (2023), 0 descendants of its own
- K223373: Enivo™ (2023), 0 descendants of its own

## Indications for use
The SOMAVAC™ Device 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/K180606
Methodology: https://510kreport.com/methodology