Cleared Traditional

K951295 - STERRAD STERILIZATION POUCH

K951295 is the FDA 510(k) clearance for STERRAD STERILIZATION POUCH by Advanced Sterilization Products. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K951295 · Advanced Sterilization Products · General Hospital
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May 1995
Decision
58d
Days
Class 2
Risk

K951295 is an FDA 510(k) clearance for the STERRAD STERILIZATION POUCH. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on May 19, 1995 after a review of 58 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 Advanced Sterilization Products devices

Submission Details

510(k) Number K951295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1995
Decision Date May 19, 1995
Days to Decision 58 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 129d · This submission: 58d
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 161
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K951295.
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AUTO SUTURE* STERILIZATION TRAY**
K954090 · United States Surgical, A Division of Tyco Healthc · Nov 1995
INSTRUMENT GUARD CAPSULE
K831588 · Treace Medical, Inc. · Jun 1983
DISPOSABLE INSTRUMENT TRAY PAD
K791412 · Anago, Inc. · Aug 1979
DISPOSABLE SURGICAL INSTRUMENT TIP
K782144 · Anago, Inc. · Jan 1979