510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904921Substantially Equivalent

Steri-Vac(tm) Aerator Model Xl

3M Company, St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904921 is the FDA 510(k) clearance record for STERI-VAC(TM) AERATOR MODEL XL, a class II device, cleared for 3M Health Care, Ltd. on under FDA product code FLI (Cabinet, Ethylene-Oxide Gas Aerator). FDA records list 58 510(k) clearances for 3M COMPANY, from to . As of , FDA records show no recalls naming K904921.

Clearance record

Decision date
Received
(35 days to decision)
Product code
FLI Cabinet, Ethylene-Oxide Gas Aerator
Regulation
21 CFR 880.6100
Device class
Class II
Review panel
General Hospital
Applicant
3M Health Care, Ltd. 3m Center, Bldg. 275-3e-08, St. Paul MN
Third party review
No

Clearances, product code FLI

Trailing 12 months

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

FDA records show no clearances under product code FLI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FLI, 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