Cleared Traditional

K090670 - MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER

K090670 is an FDA 510(k) clearance for MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER, manufactured by Midmark Corp.. The device is a Class 2 General Hospital device with 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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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

FDA 510(k) Submission Details - K090670

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.

FLE Device Classification - Class 2, Special Controls

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 130
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K090670.
BELIMED STEAM STERILIZER MST-V
K103841 · Sauter AG · Mar 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
STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101
K072466 · Scican , Ltd. · Dec 2007

FDA 510(k) Resources - General Hospital

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