Cleared Traditional

K013715 - RE-USABLE STERILIZATION POUCH / BAG

K013715 is an FDA 510(k) clearance for RE-USABLE STERILIZATION POUCH / BAG, manufactured by Quality Products of Montana. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K013715 · Quality Products of Montana · General Hospital
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Apr 2002
Decision
144d
Days
Class 2
Risk

K013715 is an FDA 510(k) clearance for the RE-USABLE STERILIZATION POUCH / BAG. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Quality Products of Montana (Missoula, US). The FDA issued a Cleared decision on April 1, 2002 after a review of 144 days - within the typical 510(k) review window.

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 Quality Products of Montana devices

FDA 510(k) Submission Details - K013715

510(k) Number K013715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2001
Decision Date April 01, 2002
Days to Decision 144 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
15d slower than avg
Panel avg: 129d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
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 - FRG Wrap, Sterilization

All 222
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K013715.
REUSABLE STERILCONTAINER FILTER MODEL #JK090
K041623 · Aesculap, Inc. · Dec 2004
APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER
K013003 · Advanced Sterilization Products · Aug 2002
GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM
K012931 · Allegiance Healthcare Corp. · Aug 2002
METAPAK MULTI-PURPOSE INSTRUMENT TRAY
K993535 · Riley Medical, Inc. · Dec 2001
MEDLINE STERILIZATION WRAP
K002968 · Medline Industries, Inc. · Jan 2001
ALLEGIANCE GENESIS CONTAINER SYSTEM
K983299 · Allegiance Healthcare Corp. · Aug 2000