Cleared Traditional

TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES (K111736) - FDA 510(k) Clearance

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

K111736 · Tuttnauer Co. , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 183
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K111736.
Enbio PRO
K260254 · Enbio Group AG · Feb 2026
Getinge GSS67N Series Steam Sterilizer
K252307 · Maquet GmbH (A Getinge Group Company) · Jan 2026
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
K250168 · Lucas Lifecare · Dec 2025
Cassette Autoclave (ACA5)
K250164 · Guangzhou Ajax Medical Equipment Co., Ltd. · Aug 2025
Steam Sterilizer (2545D)
K243994 · Ningbo Ican Machines Co., Ltd. · Jun 2025
FRONT-LINE Field Sterilizer (FL135)
K243801 · Fort Defiance Industries, LLC · Mar 2025