510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821842Substantially Equivalent

Gas Sterilization Equipment

Getinge International, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821842 is the FDA 510(k) clearance record for GAS STERILIZATION EQUIPMENT, a class II device, cleared for Getinge International, Inc. on under FDA product code FLF (Sterilizer, Ethylene-Oxide Gas). FDA records list 4 510(k) clearances for Getinge International, Inc., from to . As of , FDA records show no recalls naming K821842.

Clearance record

Decision date
Received
(36 days to decision)
Product code
FLF Sterilizer, Ethylene-Oxide Gas
Regulation
21 CFR 880.6860
Device class
Class II
Review panel
General Hospital
Applicant
Getinge International, Inc. 4221 Richmond Rd., NW, Walker MI
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