Cleared Traditional

K080198 - TSO3 OZONE STERILIZATION WRAP

K080198 is an FDA 510(k) clearance for TSO3 OZONE STERILIZATION WRAP, manufactured by Tso3, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K080198 · Tso3, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
May 2008
Decision
126d
Days
Class 2
Risk

K080198 is an FDA 510(k) clearance for the TSO3 OZONE STERILIZATION WRAP. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Tso3, Inc. (Fairport, US). The FDA issued a Cleared decision on May 30, 2008 after a review of 126 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 Tso3, Inc. devices

FDA 510(k) Submission Details - K080198

510(k) Number K080198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2008
Decision Date May 30, 2008
Days to Decision 126 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 129d · This submission: 126d
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 173
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K080198.
KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600
K091685 · Kimberly-Clark Corp. · Sep 2009
KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600
K082554 · Kimberly-Clark Corp. · May 2009
KIMGUARD ONE-STEP STERILIZATION WRAP
K082177 · Kimberly-Clark Corp. · Mar 2009
VIS-U-ALL II HEAT-SEAL POUCH AND TUBING
K071087 · STERIS Corporation · Oct 2007
CONMED LINVATEC INSTRUMENT STERILIZATION TRAY
K052992 · Conmed Linvatec · Oct 2006
AESCULAP STERILCONTAINER SYSTEM
K053389 · Aesculap, Inc. · Feb 2006