Cleared Traditional

K071783 - VERSAPOD (TM) INSTRUMENT TRAYS

K071783 is an FDA 510(k) clearance for VERSAPOD (TM) INSTRUMENT TRAYS, manufactured by Containmed, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 435-day FDA review.

K071783 · Containmed, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
435d
Days
Class 2
Risk

K071783 is an FDA 510(k) clearance for the VERSAPOD (TM) INSTRUMENT TRAYS. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Containmed, Inc. (Speedway, US). The FDA issued a Cleared decision on September 9, 2008 after a review of 435 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 Containmed, Inc. devices

FDA 510(k) Submission Details - K071783

510(k) Number K071783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2007
Decision Date September 09, 2008
Days to Decision 435 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
306d slower than avg
Panel avg: 129d · This submission: 435d
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 187
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K071783.
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SMITH & NEPHEW INSTRUMENT TRAYS
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CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY
K080531 · Conmed Linvatec · Sep 2008
AESCULAP PRIMELINE CONTAINER LTD.
K073168 · Aesculap, Inc. · Apr 2008
INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS
K072211 · Intuitive Surgical, Inc. · Feb 2008