# K021161: TSO3 Ozone Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Technologies of Sterilization With Oxone, Tso3, Inc.
- Decided: Aug 27, 2003 after 503 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) STERRAD Chemical Indicator: named in the summary without a submission number

## Indications for use
The TSO3 Chemical Indicator is a process indicator intended for use by health care providers to accompany sterilization packs, containers, or trays to be sterilized in the TSO3 Model 125L Ozone Sterilizer. It is intended to differentiate between unprocessed items and processed items. The color of the TSO3 Chemical Indicator changes from a red to lighter than the peach reference color when exposed to ozone, a critical component of the TSO3 Model 125L Sterilizer sterilization process.

Source page: https://510kreport.com/device/K021161
Methodology: https://510kreport.com/methodology