Cleared Traditional

K122774 - SAKURA STEAM STERILIZAER MODEL ASSV-AH06

Also marketed or referenced as:
SAKURA STEAM STERILIZER MODEL ASSV-AH06E SKYTRON INTEGRITY 175 SKYTRON INTEG

K122774 is an FDA 510(k) clearance for SAKURA STEAM STERILIZAER MODEL ASSV-AH06, 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 241-day FDA review.

K122774 · 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 2013
Decision
241d
Days
Class 2
Risk

K122774 is an FDA 510(k) clearance for the SAKURA STEAM STERILIZAER MODEL ASSV-AH06. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Sakura Seiki Co., Ltd. (Chikuma, Nagano, JP). The FDA issued a Cleared decision on May 9, 2013 after a review of 241 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.

FDA 510(k) Submission Details - K122774

510(k) Number K122774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2012
Decision Date May 09, 2013
Days to Decision 241 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
112d slower than avg
Panel avg: 129d · This submission: 241d
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.

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.

Regulatory Peers - FLE Sterilizer, Steam

All 153
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K122774.
BELIMED STEAM STERILIZER MST-V
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GETINGE 800HC- SERIES STEAM STERILIZER
K122625 · Getinge Sourcing, LLC · May 2013
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K122071 · Getinge Sourcing, LLC · Mar 2013
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K112872 · Scican , Ltd. · Jul 2012
GETINGE 700HC-E SERIES STEAM STERILIZER
K120441 · Getinge Sourcing, LLC · May 2012

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.