Cleared Traditional

K111736 - TUTTNAUER EZ PLUS SERIES ELECTRONIC TAB...

K111736 is the FDA 510(k) clearance for TUTTNAUER EZ PLUS SERIES ELECTRONIC TAB... by Tuttnauer Co. , Ltd.. It is a Class 2 General Hospital device (product code FLE) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K111736 · Tuttnauer Co. , Ltd. · General Hospital
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Dec 2011
Decision
171d
Days
Class 2
Risk

K111736 is an FDA 510(k) clearance for the TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Tuttnauer Co. , Ltd. (Washington, US). The FDA issued a Cleared decision on December 8, 2011 after a review of 171 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 Tuttnauer Co. , Ltd. devices

Submission Details

510(k) Number K111736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2011
Decision Date December 08, 2011
Days to Decision 171 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
42d slower than avg
Panel avg: 129d · This submission: 171d
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 64
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K111736.
Getinge GSS67N Series Steam Sterilizer
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K092490 · STERIS Corporation · Nov 2009
AMSCO EVOLUTION MEDIUM STEAM STERILIZER
K091731 · STERIS Corporation · Sep 2009