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SOMAVAC Device

by Somavac Medical Solutions, Inc.

510(k) K180606

SOMAVAC Device is a medical device (FDA Class II; FDA product code BTA, Pump, Portable, Aspiration (Manual Or Powered)) made by Somavac Medical Solutions, Inc., cleared under FDA 510(k) K180606 on 31 May 2018, active as of 23 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK180606 Date31 May 2018ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
BTA
Device class
Class II
Regulation
21 CFR Part 878.4780
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K180606

7 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K180606
UDI-DISize and differences
SOMAVAC 100 Sustained Vacuum System 10011
Somavac Medical Solutions, Inc.
10011 / 1001100850004219027 —On the market
SOMAVAC Belt 20041
Somavac Medical Solutions, Inc.
20041 / 2004100850004219058 —On the market
SOMAVAC Belt Extender 20051
Somavac Medical Solutions, Inc.
20051 / 2005100850004219065 —On the market
SOMAVAC Drain Connector - Dual Input 10061
Somavac Medical Solutions, Inc.
10061 / 1006100850004219072 —On the market
SOMAVAC Drain Connector - Dual Output 10081
Somavac Medical Solutions, Inc.
10081 / 1008100850004219096 —On the market
SOMAVAC Drain Connector 20031
Somavac Medical Solutions, Inc.
20031 / 2003100850004219034 —On the market
SOMAVAC Waste Collection Unit 20021
Somavac Medical Solutions, Inc.
20021 / 2002100850004219041 —On the market

Similar devices

Other devices filed under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)).

Other devices from Somavac Medical Solutions, Inc.

See all devices from Somavac Medical Solutions, Inc. →