Cleared Traditional

K133015 - INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM

K133015 is an FDA 510(k) clearance for INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM, manufactured by Summit Medical, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K133015

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
Combination Product No
PCCP Authorized No
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.

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 230
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K133015.
V-PRO STERILIZATION TRAY/ STERILIZATION MAT
K140494 · STERIS Corporation · Jul 2014
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
K140289 · Summit Medical, Inc. · Jun 2014
VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC
K133116 · Conmed Corporation · Mar 2014
RESTORE MODULAR STERILIZATION TRAY SYSTEM
K131455 · Restore Medical Solutions, Inc. · Aug 2013
SONICISION STERILIZATION TRAY
K131170 · Covidien, Formerly Valleylab, A Division of Tyco H · Aug 2013
ERMIS STERILIZATION CONTAINER SYSTEM
K123234 · Ermis Medizintechnik · Jul 2013