Cleared Traditional

MODEL #M8 ELECTRONIC STERILIZER

K900432 · Midmark Corp. · General Hospital
Jul 1990
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K900432 is an FDA 510(k) clearance for the MODEL #M8 ELECTRONIC STERILIZER, a Sterilizer, Steam (Class II — Special Controls, product code FLE), submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on July 27, 1990, 178 days after receiving the submission on January 30, 1990. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number K900432 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 1990
Decision Date July 27, 1990
Days to Decision 178 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FLE — Sterilizer, Steam
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6880

Similar Devices — FLE Sterilizer, Steam

All 183
Enbio PRO
K260254 · Enbio Group AG · Feb 2026
Getinge GSS67N Series Steam Sterilizer
K252307 · Maquet GmbH (A Getinge Group Company) · Jan 2026
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
K250168 · Lucas Lifecare · Dec 2025
Cassette Autoclave (ACA5)
K250164 · Guangzhou Ajax Medical Equipment Co., Ltd. · Aug 2025
Steam Sterilizer (2545D)
K243994 · Ningbo Ican Machines Co., Ltd. · Jun 2025
FRONT-LINE Field Sterilizer (FL135)
K243801 · Fort Defiance Industries, LLC · Mar 2025