Cleared Traditional

K090670 - MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER

K090670 is the FDA 510(k) clearance for MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER by Midmark Corp.. It is a Class 2 General Hospital device (product code FLE) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K090670 · Midmark Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2009
Decision
116d
Days
Class 2
Risk

K090670 is an FDA 510(k) clearance for the MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on July 7, 2009 after a review of 116 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Midmark Corp. devices

Submission Details

510(k) Number K090670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2009
Decision Date July 07, 2009
Days to Decision 116 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 129d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Intertek Testing Services
JAY Y KOGOMA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLE Sterilizer, Steam

All 70
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K090670.
AMSCO CHIMERON SMALL STEAM STERILIZER
K111223 · STERIS Corporation · Sep 2011
AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000
K092490 · STERIS Corporation · Nov 2009
AMSCO EVOLUTION MEDIUM STEAM STERILIZER
K091731 · STERIS Corporation · Sep 2009
AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200
K091136 · STERIS Corporation · Jun 2009
AMSCO EVOLUTION MEDIUM STEAM STERILIZER
K082435 · STERIS Corporation · Dec 2008
CLS-2000 UNIT
K024133 · Dentsply Intl. · Oct 2003

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.