Cleared Traditional

Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer (K163337) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163337 · Midmark Corporation · General Hospital
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Aug 2017
Decision
276d
Days
Class 2
Risk

K163337 is an FDA 510(k) clearance for the Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9.... Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Midmark Corporation (Versailles, US). The FDA issued a Cleared decision on August 31, 2017 after a review of 276 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.

View all Midmark Corporation devices

Submission Details

510(k) Number K163337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2016
Decision Date August 31, 2017
Days to Decision 276 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 129d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - FLE Sterilizer, Steam

All 62
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K163337.
Amsco Evolution Medium Steam Sterilizer
K173485 · STERIS Corporation · Feb 2018
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
K173490 · STERIS Corporation · Feb 2018
Getinge GSS67N Series Steam Sterilizer
K172159 · Maquet GmbH · Jan 2018
AMSCO CHIMERON MEDIUM STEAM STERLILZER
K112403 · STERIS Corporation · May 2012
AMSCO CHIMERON MEDIUM STEAM STERILIZER
K112055 · STERIS Corporation · Dec 2011
AMSCO CHIMERON SMALL STEAM STERILIZER
K111223 · STERIS Corporation · Sep 2011