510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900432Substantially Equivalent

Model #M8 Electronic Sterilizer

Midmark Corp, Versailles OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900432 is the FDA 510(k) clearance record for MODEL #M8 ELECTRONIC STERILIZER, a class II device, cleared for Midmark Corp. on under FDA product code FLE (Sterilizer, Steam). FDA records list 39 510(k) clearances for Midmark Corp., from to . As of , FDA records show no recalls naming K900432.

Clearance record

Decision date
Received
(178 days to decision)
Product code
FLE Sterilizer, Steam
Regulation
21 CFR 880.6880
Device class
Class II
Review panel
General Hospital
Applicant
Midmark Corp. 60 Vista Dr., Versailles OH
Third party review
No

Clearances, product code FLE

Trailing 12 months
4 clearances under product code FLE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FLE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20261
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260