Cleared Traditional

K132439 - SAKURA STEAM STERILIZER ASSR (FDA 510(k) Clearance)

Also includes:
-AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270 STEAM STERILIZER,VP STEAM STERILIZER

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

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

Submission Details

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.

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 K132439.
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