Cleared Traditional

MILTEX THOMPSON CASSETTES (K101653) - FDA 510(k) Clearance

Also marketed or referenced as:
MILTEX SURGICAL CASSETTES

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K101653 · Miltex, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
52d
Days
Class 2
Risk

K101653 is an FDA 510(k) clearance for the MILTEX THOMPSON CASSETTES. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Miltex, Inc. (York, US). The FDA issued a Cleared decision on August 2, 2010 after a review of 52 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 Miltex, Inc. devices

Submission Details

510(k) Number K101653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2010
Decision Date August 02, 2010
Days to Decision 52 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 129d · This submission: 52d
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 135
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K101653.
STERILIZATION MATS
K103226 · STERIS Corporation · Feb 2011
SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428
K102122 · Smith & Nephew, Inc. · Nov 2010
VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU
K092745 · STERIS Corporation · Nov 2010
CODMAN STERILIZATION CONTAINERS
K092437 · Codman & Shurtleff, Inc. · Mar 2010
KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS
K090818 · KARL STORZ Endoscopy-America, Inc. · Aug 2009
SMITH & NEPHEW INSTRUMENT TRAYS
K091627 · Smith & Nephew, Inc. · Jul 2009