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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Tuv Sud America, Inc.
DAWN TIBODEAU

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.