Cleared Traditional

K951295 - STERRAD STERILIZATION POUCH

K951295 is an FDA 510(k) clearance for STERRAD STERILIZATION POUCH, manufactured by Advanced Sterilization Products. The device is a Class 2 General Hospital device with 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.

FDA 510(k) Submission Details - K951295

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.

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 K951295.
SAFE-T-SEAL
K953829 · Gs Medical Packaging, Inc. · Nov 1995
MEDI-OXIDE STERILZATION POUCH FROM MEDI-PLUS
K953749 · Curwood, Inc. · Oct 1995
STERIKING STERILIZATION POUCHES & ROLLS
K953776 · Wihuri OY · Oct 1995
ASSURE, SELF-SEALING STERILIZATION POUCH
K951590 · Sultan Chemists, Inc. · May 1995
THE ULTRA
K935755 · Medical Device Systems, Inc. · May 1995
CROSSTEX SELF-SEALING STERILIZATION POUCH
K941327 · Cross Country Paper Products Corp. · Dec 1994
K951295 · STERRAD STERILIZATION POUCH
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