Cleared Traditional

K233413 - Ultraphon Chemical Indicator (TRO-T and...

K233413 is an FDA 510(k) clearance for Ultraphon Chemical Indicator (TRO-T and..., manufactured by True Indicating, LLC. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K233413 · True Indicating, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
264d
Days
Class 2
Risk

K233413 is an FDA 510(k) clearance for the Ultraphon Chemical Indicator (TRO-T and TRO-B). Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by True Indicating, LLC (Toledo, US). The FDA issued a Cleared decision on June 26, 2024 after a review of 264 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 True Indicating, LLC devices

FDA 510(k) Submission Details - K233413

510(k) Number K233413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2023
Decision Date June 26, 2024
Days to Decision 264 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
135d slower than avg
Panel avg: 129d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOJ Device Classification - Class 2, Special Controls

Product Code JOJ Indicator, Physical/chemical 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 - JOJ Indicator, Physical/chemical Sterilization Process

All 153
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