Cleared Traditional

Pre-vacuum Tabletop Autoclave (K143311) - FDA 510(k) Clearance

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

K143311 · Tuttnauer U.S.A Co, Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Jan 2015
Decision
58d
Days
Class 2
Risk

K143311 is an FDA 510(k) clearance for the Pre-vacuum Tabletop Autoclave. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Tuttnauer U.S.A Co, Ltd. (Hauppauge, US). The FDA issued a Cleared decision on January 15, 2015 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tuttnauer U.S.A Co, Ltd. devices

Submission Details

510(k) Number K143311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2014
Decision Date January 15, 2015
Days to Decision 58 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
71d faster than avg
Panel avg: 129d · This submission: 58d
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 K143311.
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