Cleared Traditional

K922440 - STERIKING, SEE & PEEL

K922440 is an FDA 510(k) clearance for STERIKING, manufactured by Cox Sterile Products, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 857-day FDA review.

K922440 · Cox Sterile Products, Inc. · General Hospital
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Sep 1994
Decision
857d
Days
Class 2
Risk

K922440 is an FDA 510(k) clearance for the STERIKING, SEE & PEEL. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Cox Sterile Products, Inc. (Dallas, US). The FDA issued a Cleared decision on September 26, 1994 after a review of 857 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Cox Sterile Products, Inc. devices

FDA 510(k) Submission Details - K922440

510(k) Number K922440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1992
Decision Date September 26, 1994
Days to Decision 857 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
728d slower than avg
Panel avg: 129d · This submission: 857d
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 244
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K922440.
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STERRAD STERILIZATION POUCH
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BARRIER PLASTIC PACKAGING (MODIFICATION)
K933560 · Maxxim Medical · Apr 1994
SHAVE PREP TRAY
K935739 · Cush Medical Products · Feb 1994
CAM-WRAP(TM) NEW STERILIZATION PROCEDURE
K891983 · Medical Dynamics, Inc. · Apr 1989