Cleared Traditional

K163337 - Midmark and Ritter M9 and M11 UltraClav...

K163337 is an FDA 510(k) clearance for Midmark and Ritter M9 and M11 UltraClav..., manufactured by Midmark Corporation. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 276-day FDA review.

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

FDA 510(k) Submission Details - K163337

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.

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 76
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