Cleared Traditional

K936181 - MIDMARK M-11 ULTRACLAVE STEAM STERILIZER

K936181 is an FDA 510(k) clearance for MIDMARK M-11 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 338-day FDA review.

K936181 · Midmark Corp. · General Hospital
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Nov 1994
Decision
338d
Days
Class 2
Risk

K936181 is an FDA 510(k) clearance for the MIDMARK M-11 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 November 30, 1994 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K936181

510(k) Number K936181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1993
Decision Date November 30, 1994
Days to Decision 338 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 129d · This submission: 338d
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 K936181.
BUXTON BUILT STERILIZER, BUXTON BUILT RECONDITIONED STERILIZER
K951273 · Buxton Medical Servic Corp. · Aug 1995
OCR II & OCM II
K942989 · Chambermaid Products Co. · Jul 1995
BARNARD & ASSOCIATES REMANUFACTURED GENERAL PURPOSE, VACUUM OR LABORATORY STERILIZER
K950341 · Barnard and Assoc. · Apr 1995
PRIMUS PSS SERIES STERILIZERS
K926185 · Primus Sterilizer Co., Inc. · May 1994
SES-2012 AUTOMATIC STEAM STERILIZER
K924596 · Porter Instrument Co., Inc. · Apr 1994
MDT/HARVEY MC-8 AND MC-10
K924955 · Mdt Corp., Inc. · Oct 1993
K936181 · MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
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