Cleared Traditional

K140487 - VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING

K140487 is an FDA 510(k) clearance for VIS-U-ALL LOW TEMPERATURE STERILIZATION..., manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K140487 · STERIS Corporation · General Hospital
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Jul 2014
Decision
145d
Days
Class 2
Risk

K140487 is an FDA 510(k) clearance for the VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on July 22, 2014 after a review of 145 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 STERIS Corporation devices

FDA 510(k) Submission Details - K140487

510(k) Number K140487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2014
Decision Date July 22, 2014
Days to Decision 145 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 129d · This submission: 145d
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 184
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K140487.
Gemini Bonded Sterilization Wrap
K143147 · Medline Industries, Inc. · May 2015
Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
K141693 · Advanced Sterilization Products · Dec 2014
KIMGUARD SMART-FOLD STERILIZATION WRAP
K140963 · Kimberly-Clark Corp. · Nov 2014
DURABLUE STERILIZATION WRAP
K130927 · Cardinal Health200, LLC · Jun 2013
GEMINI STERILZATION WRAP
K113353 · Medline Industries, Inc. · Jan 2013
DURABLUE STERILIZATION WRAP
K123857 · Cardinal Health200, LLC · Jan 2013