Cleared Traditional

K091720 - SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM

K091720 is an FDA 510(k) clearance for SKLARLITE RIGID STERILIZATION CONTAINER..., manufactured by Sklar Corp.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K091720 · Sklar Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
302d
Days
Class 2
Risk

K091720 is an FDA 510(k) clearance for the SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Sklar Corp. (Great Neck, US). The FDA issued a Cleared decision on April 9, 2010 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K091720

510(k) Number K091720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2009
Decision Date April 09, 2010
Days to Decision 302 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
173d slower than avg
Panel avg: 129d · This submission: 302d
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 268
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K091720.
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CODMAN STERILIZATION CONTAINERS
K092437 · Codman & Shurtleff, Inc. · Mar 2010
CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM
K092414 · Conmed Corporation · Mar 2010
POGO SCREW INSTRUMENTATION TRAY
K091806 · Fxdevices · Feb 2010
K091720 · SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM
Download PDF FDA Summary Sklar Corp.