Cleared Special

K090562 - SMITH & NEPHEW INSTRUMENT TRAYS

K090562 is an FDA 510(k) clearance for SMITH & NEPHEW INSTRUMENT TRAYS, manufactured by Smith & Nephew, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Special 510(k) pathway after a 16-day FDA review.

K090562 · Smith & Nephew, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
16d
Days
Class 2
Risk

K090562 is an FDA 510(k) clearance for the SMITH & NEPHEW INSTRUMENT TRAYS. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Mansfield, US). The FDA issued a Cleared decision on March 18, 2009 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K090562

510(k) Number K090562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2009
Decision Date March 18, 2009
Days to Decision 16 days
Submission Type Special
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
113d faster than avg
Panel avg: 129d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 283
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K090562.
SMITH & NEPHEW INSTRUMENT TRAYS
K091627 · Smith & Nephew, Inc. · Jul 2009
CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS
K090560 · Conmed Linvatec · Jun 2009
VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM
K090371 · STERIS Corporation · May 2009
VERSAPOD (TM) INSTRUMENT TRAYS
K071783 · Containmed, Inc. · Sep 2008
CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY
K080531 · Conmed Linvatec · Sep 2008
SMITH & NEPHEW INSTRUMENT TRAYS
K073551 · Smith & Nephew Inc., Endoscopy Div. · May 2008
K090562 · SMITH & NEPHEW INSTRUMENT TRAYS
Download PDF FDA Summary Smith & Nephew, Inc.