Cleared Traditional

K152241 - Medtronic Transportation/Sterilization Cassettes

K152241 is an FDA 510(k) clearance for Medtronic Transportation/Sterilization ..., manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K152241 · Medtronic Sofamor Danek USA, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
163d
Days
Class 2
Risk

K152241 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 January 20, 2016 after a review of 163 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 Medtronic Sofamor Danek USA, Inc. devices

FDA 510(k) Submission Details - K152241

510(k) Number K152241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2015
Decision Date January 20, 2016
Days to Decision 163 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
34d slower than avg
Panel avg: 129d · This submission: 163d
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 232
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K152241.
Genesis Low Temperature Reusable Rigid Container System
K153554 · Carefusion 2200, Inc. · Mar 2016
M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)
K152743 · Microline Surgical, Inc. · Feb 2016
Ellipse Supplemental Instrument Trays
K151594 · Ellipse Technologies, Incorporated · Jan 2016
Endoscope Sterilization Tray
K151450 · Intuitive Surgical, Inc. · Jan 2016
Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray
K152951 · Paragon Medical, Inc. · Dec 2015
INSTRUMENT CASSETTE (EFCCL1-F)
K141854 · Osung Mnd Co., Ltd. · Oct 2015