# K141698: Sterizone Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Tso3, Inc.
- Decided: Dec 17, 2014 after 176 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
Longest line of descent: 3 generations back to K994055 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091174: Verify V-Pro Chemical Indicator, Version 1A: Verify V-Pro Chemical Indicator; Version 2A: Adhesive Label, STERIS Corporation (2009) Summary page 5.

## Indications for use
The STERIZONE® CI+ Chemical Indicator is a single-use process indicator intended to distinguish between processed and unprocessed packaged medical devices to be sterilized using the STERIZONE® VP4 Sterilizer. The device is intended for use only with the STERIZONE® VP4 Sterilizer, which has a single sterilization cycle (“Cycle 1”). Critical process parameters for Cycle 1 are summarized in Table 1. The red stripe chemical indicator is located above the peach-colored stripe labeled as the “REFERENCE”. After exposure to the Cycle 1 of the STERIZONE® VP4 Sterilizer, the chemical indicator color changes from red to peach-Reference color (or lighter).

Source page: https://510kreport.com/device/K141698
Methodology: https://510kreport.com/methodology