Cleared Traditional

K120149 - SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA

K120149 is an FDA 510(k) clearance for SKYRON INTEGRITY 215 STEAM STERILIZER S..., 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 111-day FDA review.

K120149 · Sakura Seiki Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
May 2012
Decision
111d
Days
Class 2
Risk

K120149 is an FDA 510(k) clearance for the SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZ.... 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 May 8, 2012 after a review of 111 days - within the typical 510(k) review window.

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 - K120149

510(k) Number K120149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2012
Decision Date May 08, 2012
Days to Decision 111 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
18d faster than avg
Panel avg: 129d · This submission: 111d
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 K120149.
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