Cleared Traditional

K954090 - AUTO SUTURE* STERILIZATION TRAY**

K954090 is the FDA 510(k) clearance for AUTO SUTURE* STERILIZATION TRAY** by United States Surgical, A Division of Tyco Healthc. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K954090 · United States Surgical, A Division of Tyco Healthc · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
83d
Days
Class 2
Risk

K954090 is an FDA 510(k) clearance for the AUTO SUTURE* STERILIZATION TRAY**. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on November 22, 1995 after a review of 83 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K954090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1995
Decision Date November 22, 1995
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 165
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K954090.
PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE
K042062 · Bard Peripheral Vascular, Inc. · Sep 2004
OLYMPUS STERILIZATION TRAYS
K033222 · Olympus Winter & Ibe GmbH · Aug 2004
KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION
K973827 · Kimberly-Clark Corp. · Feb 1998
STERRAD STERILIZATION POUCH
K951295 · Advanced Sterilization Products · May 1995
THE KEYMED FIBERSCOPE STERILIZATION CASE
K860528 · Keymed, Inc. · Jul 1986
INSTRUMENT GUARD CAPSULE
K831588 · Treace Medical, Inc. · Jun 1983