Cleared Traditional

K163279 - Medtronic Transportation/Sterilization ...

K163279 is the FDA 510(k) clearance for Medtronic Transportation/Sterilization ... by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K163279 · Medtronic Sofamor Danek USA, Inc. · General Hospital
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Feb 2017
Decision
94d
Days
Class 2
Risk

K163279 is an FDA 510(k) clearance for the Medtronic Transportation/Sterilization Cassettes. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on February 23, 2017 after a review of 94 days - within the typical 510(k) review window.

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 Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K163279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2016
Decision Date February 23, 2017
Days to Decision 94 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
35d faster than avg
Panel avg: 129d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 162
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K163279.
Endoscope Sterilization Tray
K170640 · Intuitive Surgical, Inc. · Sep 2017
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K163598 · Advanced Sterilization Products · Jul 2017
SterilContainer S System
K162815 · Aesculap, Inc. · Jul 2017
Sterilization Tray
K160912 · STERIS Corporation · Oct 2016
Signia sterilization tray
K161347 · Covidien · Sep 2016
ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY
K152969 · Conmed Corporation · Mar 2016