Cleared Traditional

K133015 - INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM

K133015 is the FDA 510(k) clearance for INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM by Summit Medical, Inc.. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K133015 · Summit Medical, Inc. · General Hospital
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Mar 2014
Decision
169d
Days
Class 2
Risk

K133015 is an FDA 510(k) clearance for the INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Summit Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 13, 2014 after a review of 169 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Summit Medical, Inc. devices

Submission Details

510(k) Number K133015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2013
Decision Date March 13, 2014
Days to Decision 169 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 129d · This submission: 169d
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 162
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K133015.
SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM
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VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC
K133116 · Conmed Corporation · Mar 2014
DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343
K123175 · Conmed Corporation · Feb 2013
MYOSURE INTRUMENT TRAY
K121280 · Hologic, Inc. · Feb 2013
THS INSTRUMENT TRAY
K120947 · Hologic, Inc. · Oct 2012