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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Consultant

Im3, Inc.
THOMAS RICHARDS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.