510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K803232Substantially Equivalent

Compressed Air & Oxygen Gen./delivery Sy

Dri-Aire, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K803232 is the FDA 510(k) clearance record for COMPRESSED AIR & OXYGEN GEN./DELIVERY SY, a class II device, cleared for Dri-Aire, Inc. on under FDA product code CAW (Generator, Oxygen, Portable). FDA records list one 510(k) clearance for Dri-Aire, Inc. As of , FDA records show no recalls naming K803232.

Clearance record

Decision date
Received
(42 days to decision)
Product code
CAW Generator, Oxygen, Portable
Regulation
21 CFR 868.5440
Device class
Class II
Review panel
Anesthesiology
Applicant
Dri-Aire, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code CAW

Trailing 12 months
12 clearances under product code CAW in the twelve months to October 2026, December 2025 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code CAW, trailing twelve months
MonthClearances
November 20251
December 20255
January 20260
February 20260
March 20261
April 20261
May 20261
June 20261
July 20260
August 20261
September 20261
October 20260