Cleared Traditional

K141513 - INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM

K141513 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 189-day FDA review.

K141513 · Summit Medical, Inc. · General Hospital
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Dec 2014
Decision
189d
Days
Class 2
Risk

K141513 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 December 15, 2014 after a review of 189 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 - K141513

510(k) Number K141513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2014
Decision Date December 15, 2014
Days to Decision 189 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
60d slower than avg
Panel avg: 129d · This submission: 189d
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 K141513.
STERILUCENT STERILIZATION CONTAINER SYSTEM
K142109 · Sterilucent, Inc. · Jan 2015
Genesis Reusable Rigid Container System
K142529 · Carefusion 2200, Inc. · Jan 2015
Instru-Safe Instrument Protection System
K142630 · Summit Medical, Inc. · Dec 2014
STERILIZATION CASSETTE
K141616 · Oticon Medical AB · Sep 2014
GENESIS REUSABLE RIGID CONTAINER SYSTEM
K140850 · Carefusion 2200, Inc. · Aug 2014
SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM
K130720 · Synthes USA Products, LLC · Aug 2014