Cleared Traditional

K132439 - SAKURA STEAM STERILIZER ASSR

Also marketed or referenced as:
-AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270 STEAM STERILIZER,VP STEAM STERILIZER

K132439 is an FDA 510(k) clearance for SAKURA STEAM STERILIZER ASSR, manufactured by Sakura Seiki Co., Ltd.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K132439 · Sakura Seiki Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
154d
Days
Class 2
Risk

K132439 is an FDA 510(k) clearance for the SAKURA STEAM STERILIZER ASSR. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Sakura Seiki Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on January 6, 2014 after a review of 154 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 Sakura Seiki Co., Ltd. devices

FDA 510(k) Submission Details - K132439

510(k) Number K132439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2013
Decision Date January 06, 2014
Days to Decision 154 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 129d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 87
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K132439.
Getinge GSS67N Series Steam Sterilizer
K172159 · Maquet GmbH · Jan 2018
Family of Steam sterilizers B17 B22 Series
K161848 · Cefla S.C. · Feb 2017
Family of Steam Sterilizers B 28 series
K151597 · Cefla S.C. · Mar 2016
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