510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941748Substantially Equivalent

Steri-Vac Gas Sterilizer Model 8Xl

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

K941748 is the FDA 510(k) clearance record for STERI-VAC GAS STERILIZER MODEL 8XL, a class II device, cleared for 3M Health Care, Ltd. on under FDA product code FLF (Sterilizer, Ethylene-Oxide Gas). FDA records list 58 510(k) clearances for 3M COMPANY, from to . As of , FDA records show 3 recalls naming K941748.

Clearance record

Decision date
Received
(238 days to decision)
Product code
FLF Sterilizer, Ethylene-Oxide Gas
Regulation
21 CFR 880.6860
Device class
Class II
Review panel
General Hospital
Applicant
3M Health Care, Ltd. 3m Center, Bldg. 275-3e-08, St. Paul MN
510(k) summary
Summary
Third party review
No

Clearances, product code FLF

Trailing 12 months

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

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