Cleared Traditional

K932056 - DEFEND SELF-SEALING STERILIZATION POUCH

K932056 is an FDA 510(k) clearance for DEFEND SELF-SEALING STERILIZATION POUCH, manufactured by Carl Parker Associates, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 441-day FDA review.

K932056 · Carl Parker Associates, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
441d
Days
Class 2
Risk

K932056 is an FDA 510(k) clearance for the DEFEND SELF-SEALING STERILIZATION POUCH. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Carl Parker Associates, Inc. (Hauppauge, US). The FDA issued a Cleared decision on July 13, 1994 after a review of 441 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.

FDA 510(k) Submission Details - K932056

510(k) Number K932056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1993
Decision Date July 13, 1994
Days to Decision 441 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
312d slower than avg
Panel avg: 129d · This submission: 441d
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 267
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K932056.
AUTOPAK INSTRUMENT TRAY STERILIZATION POUCH
K932086 · Ongard Meddevice Packaging, Inc. · Nov 1994
AUTOPAK STERILIZATION POUCH
K932088 · Ongard Meddevice Packaging, Inc. · Nov 1994
STERIKING, SEE & PEEL
K922440 · Cox Sterile Products, Inc. · Sep 1994
ASSURE SELF SEALING STERILIZATION POUCH
K933729 · Sultan Chemists, Inc. · Jun 1994
STERITUBE
K930072 · Jordco, Inc. · Jun 1994
RPPI STERILIZATION BAGS
K934252 · Royal Precision Plastics, Inc. · Jun 1994
K932056 · DEFEND SELF-SEALING STERILIZATION POUCH
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