510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K890438Substantially Equivalent

Gas-Vak(r), Model 300

Gas-Vak, Westwood CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890438 is the FDA 510(k) clearance record for GAS-VAK(R), MODEL 300, a class II device, cleared for Gas-Vak on under FDA product code CBN (Apparatus, Gas-Scavenging). FDA records list 2 510(k) clearances for Gas-Vak, from to . As of , FDA records show no recalls naming K890438.

Clearance record

Decision date
Received
(188 days to decision)
Product code
CBN Apparatus, Gas-Scavenging
Regulation
21 CFR 868.5430
Device class
Class II
Review panel
Anesthesiology
Applicant
Gas-Vak P.O. Box 941, Westwood CA
Third party review
No

Clearances, product code CBN

Trailing 12 months

FDA records hold no clearances under product code CBN in the trailing twelve months.

FDA records show no clearances under product code CBN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CBN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260