Cleared Traditional

K092745 - VIS-U-ALL LOW TEMPERATURE TYVEK STERILI...

K092745 is the FDA 510(k) clearance for VIS-U-ALL LOW TEMPERATURE TYVEK STERILI... by STERIS Corporation. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 437-day FDA review.

K092745 · STERIS Corporation · General Hospital
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Nov 2010
Decision
437d
Days
Class 2
Risk

K092745 is an FDA 510(k) clearance for the VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODEL.... Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on November 19, 2010 after a review of 437 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all STERIS Corporation devices

Submission Details

510(k) Number K092745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2009
Decision Date November 19, 2010
Days to Decision 437 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
308d slower than avg
Panel avg: 129d · This submission: 437d
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 153
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K092745.
CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM
K120117 · Codman & Shurtleff, Inc. · Apr 2012
STERILIZATION MATS
K103226 · STERIS Corporation · Feb 2011
SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428
K102122 · Smith & Nephew, Inc. · Nov 2010
CODMAN STERILIZATION CONTAINERS
K092437 · Codman & Shurtleff, Inc. · Mar 2010
CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM
K092414 · Conmed Corporation · Mar 2010
KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS
K090818 · KARL STORZ Endoscopy-America, Inc. · Aug 2009