Cleared Traditional

K153689 - STERIZONE Sterilizer

K153689 is an FDA 510(k) clearance for STERIZONE Sterilizer, manufactured by Tso3, Inc.. The device is a Class 2 General Hospital device with product code PJJ cleared through the Traditional 510(k) pathway after a 190-day FDA review.

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

FDA 510(k) Submission Details - K153689

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.

PJJ Device Classification - Class 2, Special Controls

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.