Cleared Traditional

K152969 - ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY

K152969 is an FDA 510(k) clearance for ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY, manufactured by Conmed Corporation. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K152969 · Conmed Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
175d
Days
Class 2
Risk

K152969 is an FDA 510(k) clearance for the ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on March 31, 2016 after a review of 175 days - an extended review cycle.

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 Conmed Corporation devices

FDA 510(k) Submission Details - K152969

510(k) Number K152969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2015
Decision Date March 31, 2016
Days to Decision 175 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
46d slower than avg
Panel avg: 129d · This submission: 175d
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 181
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K152969.
Medtronic Transportation/Sterilization Cassettes
K163279 · Medtronic Sofamor Danek USA, Inc. · Feb 2017
Sterilization Tray
K160912 · STERIS Corporation · Oct 2016
Signia sterilization tray
K161347 · Covidien · Sep 2016
Medtronic Transportation/Sterilization Cassettes
K152241 · Medtronic Sofamor Danek USA, Inc. · Jan 2016
Endoscope Sterilization Tray
K151450 · Intuitive Surgical, Inc. · Jan 2016
SterilContainer S
K151242 · Aesculap, Inc. · Oct 2015