Cleared Traditional

STERIZONE Sterilizer (K153689) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K153689 · Tso3, Inc. · General Hospital
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Jun 2016
Decision
190d
Days
Class 2
Risk

K153689 is an FDA 510(k) clearance for the STERIZONE Sterilizer. Classified as Two Or More Sterilant Sterilizer (product code PJJ), Class II - Special Controls.

Submitted by Tso3, Inc. (Quebec, CA). The FDA issued a Cleared decision on June 30, 2016 after a review of 190 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6860 - 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

Submission Details

510(k) Number K153689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2015
Decision Date June 30, 2016
Days to Decision 190 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
61d slower than avg
Panel avg: 129d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PJJ Two Or More Sterilant Sterilizer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6860
Definition Intended For Use In Terminal Sterilization Of Cleaned, Rinsed, And Dried Metal And Non-metal Reusable Medical Devices In Health Care Facilities.
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.