Cleared Abbreviated

SMITH & NEPHEW INSTRUMENT TRAYS (K073551) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K073551 · Smith & Nephew Inc., Endoscopy Div. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
155d
Days
Class 2
Risk

K073551 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., Endoscopy Div. (Mansfield, US). The FDA issued a Cleared decision on May 21, 2008 after a review of 155 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smith & Nephew Inc., Endoscopy Div. devices

Submission Details

510(k) Number K073551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2007
Decision Date May 21, 2008
Days to Decision 155 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 129d · This submission: 155d
Pathway characteristics
Standards-based clearance path.

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 140
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K073551.
SMITH & NEPHEW INSTRUMENT TRAYS
K091627 · Smith & Nephew, Inc. · Jul 2009
VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM
K090371 · STERIS Corporation · May 2009
SMITH & NEPHEW INSTRUMENT TRAYS
K090562 · Smith & Nephew, Inc. · Mar 2009
AESCULAP PRIMELINE CONTAINER LTD.
K073168 · Aesculap, Inc. · Apr 2008
INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS
K072211 · Intuitive Surgical, Inc. · Feb 2008
VIS-U-ALL II SELF SEAL POUCH
K070765 · STERIS Corporation · Oct 2007