510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812867Substantially Equivalent

Steri-Vac #400C Gas Sterilizer

3M Company, Monrovia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812867 is the FDA 510(k) clearance record for STERI-VAC #400C GAS STERILIZER, a class II device, cleared for 3M Company on under FDA product code FLF (Sterilizer, Ethylene-Oxide Gas). FDA records list 13 510(k) clearances for 3M Company, from to . As of , FDA records show one recall naming K812867.

Clearance record

Decision date
Received
(20 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 Company 2724 S. Peck Rd., Monrovia CA
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