Cleared Traditional

K121904 - GYNECOLOGY STERILIZATION TRAY

K121904 is the FDA 510(k) clearance for GYNECOLOGY STERILIZATION TRAY by Smith & Nephew Inc., Endoscopy Division. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K121904 · Smith & Nephew Inc., Endoscopy Division · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
255d
Days
Class 2
Risk

K121904 is an FDA 510(k) clearance for the GYNECOLOGY STERILIZATION TRAY. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Smith & Nephew Inc., Endoscopy Division (Andover, US). The FDA issued a Cleared decision on March 11, 2013 after a review of 255 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 Smith & Nephew Inc., Endoscopy Division devices

Submission Details

510(k) Number K121904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2012
Decision Date March 11, 2013
Days to Decision 255 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
126d slower than avg
Panel avg: 129d · This submission: 255d
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 K121904.
SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM
K130720 · Synthes USA Products, LLC · Aug 2014
V-PRO STERILIZATION TRAY/ STERILIZATION MAT
K140494 · STERIS Corporation · Jul 2014
VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC
K133116 · Conmed Corporation · Mar 2014
DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343
K123175 · Conmed Corporation · Feb 2013
MYOSURE INTRUMENT TRAY
K121280 · Hologic, Inc. · Feb 2013
THS INSTRUMENT TRAY
K120947 · Hologic, Inc. · Oct 2012