Cleared Traditional

K131170 - SONICISION STERILIZATION TRAY

K131170 is an FDA 510(k) clearance for SONICISION STERILIZATION TRAY, manufactured by Covidien, Formerly Valleylab, A Division of Tyco H. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K131170 · Covidien, Formerly Valleylab, A Division of Tyco H · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
126d
Days
Class 2
Risk

K131170 is an FDA 510(k) clearance for the SONICISION STERILIZATION TRAY. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Covidien, Formerly Valleylab, A Division of Tyco H (Boulder, US). The FDA issued a Cleared decision on August 28, 2013 after a review of 126 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.

FDA 510(k) Submission Details - K131170

510(k) Number K131170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2013
Decision Date August 28, 2013
Days to Decision 126 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
3d faster than avg
Panel avg: 129d · This submission: 126d
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 K131170.
VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC
K133116 · Conmed Corporation · Mar 2014
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
K133015 · Summit Medical, Inc. · Mar 2014
RESTORE MODULAR STERILIZATION TRAY SYSTEM
K131455 · Restore Medical Solutions, Inc. · Aug 2013
ERMIS STERILIZATION CONTAINER SYSTEM
K123234 · Ermis Medizintechnik · Jul 2013
IDRIVE ULTRA STERILIZATION TRAY
K130532 · Covidien, Formerly US Surgical A Divison of Tyco H · May 2013
GYNECOLOGY STERILIZATION TRAY
K121904 · Smith & Nephew Inc., Endoscopy Division · Mar 2013