Cleared Traditional

K092682 - GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS

K092682 is an FDA 510(k) clearance for GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-S..., manufactured by Gyrus Acmi, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K092682 · Gyrus Acmi, Inc. · General Hospital
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Dec 2009
Decision
101d
Days
Class 2
Risk

K092682 is an FDA 510(k) clearance for the GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on December 11, 2009 after a review of 101 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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 Gyrus Acmi, Inc. devices

FDA 510(k) Submission Details - K092682

510(k) Number K092682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2009
Decision Date December 11, 2009
Days to Decision 101 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 129d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 227
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K092682.
MILTEX THOMPSON CASSETTES
K101653 · Miltex, Inc. · Aug 2010
CODMAN STERILIZATION CONTAINERS
K092437 · Codman & Shurtleff, Inc. · Mar 2010
CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM
K092414 · Conmed Corporation · Mar 2010
KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS
K090818 · KARL STORZ Endoscopy-America, Inc. · Aug 2009
SMITH & NEPHEW INSTRUMENT TRAYS
K091627 · Smith & Nephew, Inc. · Jul 2009
CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS
K090560 · Conmed Linvatec · Jun 2009