Cleared Traditional

K141580 - STERIZONE SELF-CONTAINED BIOLOGICAL IND...

K141580 is an FDA 510(k) clearance for STERIZONE SELF-CONTAINED BIOLOGICAL IND..., manufactured by Tso3, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K141580 · Tso3, Inc. · General Hospital
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Dec 2014
Decision
187d
Days
Class 2
Risk

K141580 is an FDA 510(k) clearance for the STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Tso3, Inc. (Vancouver, US). The FDA issued a Cleared decision on December 17, 2014 after a review of 187 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - 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 - K141580

510(k) Number K141580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2014
Decision Date December 17, 2014
Days to Decision 187 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
58d slower than avg
Panel avg: 129d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRC Device Classification - Class 2, Special Controls

Product Code FRC Indicator, Biological Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
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 - FRC Indicator, Biological Sterilization Process

All 143
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K140392 · 3M Company · Aug 2014