Cleared Traditional

K954090 - AUTO SUTURE* STERILIZATION TRAY**

K954090 is an FDA 510(k) clearance for AUTO SUTURE* STERILIZATION TRAY**, manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K954090

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.

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 238
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K954090.
REXAM SELF-SEAL TYVEK POUCH
K962600 · Rexam Medical Packaging, Inc. · Aug 1996
OXBORO-MEDICAL FOAM INSTRUMENT HOLDER
K953068 · Oxboro Medical Intl., Inc. · Jan 1996
RE-BAG MULTI-USE POUCH, LARGE & SMALL
K954185 · Miltex, Inc. · Dec 1995
STERRAD STERILIZATION POUCH
K951295 · Advanced Sterilization Products · May 1995
BARRIER PLASTIC PACKAGING (MODIFICATION)
K933560 · Maxxim Medical · Apr 1994
SHAVE PREP TRAY
K935739 · Cush Medical Products · Feb 1994