Cleared Traditional

K911322 - MODEL #M9 ULTRACLAVE STEAM STERILIZER

K911322 is an FDA 510(k) clearance for MODEL #M9 ULTRACLAVE STEAM 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 153-day FDA review.

K911322 · Midmark Corp. · General Hospital
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Aug 1991
Decision
153d
Days
Class 2
Risk

K911322 is an FDA 510(k) clearance for the MODEL #M9 ULTRACLAVE STEAM 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 August 26, 1991 after a review of 153 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K911322

510(k) Number K911322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1991
Decision Date August 26, 1991
Days to Decision 153 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 129d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - FLE Sterilizer, Steam

All 185
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K911322.
MAXIMA-10
K911206 · Stirn Industries · Nov 1991
STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)
K910778 · Mdt Biologic Co. · Oct 1991
KAVOKLAVE STEAM AUTOCLAVE
K910789 · Kavo America · Aug 1991
STATIM CASSETTE AUTOCLAVE
K910241 · Scican · May 1991
HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE
K903614 · Harvard Apparatus, Inc. · Dec 1990
JOSLYN STEAM STERILIZER / STEAM MODERNIZATION KIT
K901147 · Joslyn Valve Corp. · Nov 1990
K911322 · MODEL #M9 ULTRACLAVE STEAM STERILIZER
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