# K220778: Chemical Indicator for Steam

- Pathway: 510(k) (Traditional)
- Applicant: True Indicating, LLC
- Decided: Dec 2, 2022 after 260 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 K932129 (1994). 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)
- K181788: Lead-free Chemical Indicators for Steam Sterilization, Kem Medical Products Corp. (2019) Summary page 4.

## Indications for use
The Chemical Indicator for Steam is intended for use with individual materials (i.e. pouches, packs, trays) to demonstrate the material has been exposed to a steam sterilization process to distinguish between processed and unprocessed goods. The Chemical Indicator for Steam can transition from an initial color of yellow and turn to a dark brown/black color for Product Code: CSYN-US, pink to a dark brown/black color for Product Code: CSPN-US, and blue to a dark brown/black color for Product Code: CSBN-US when exposed to high temperature steam at the following time and temperature intervals as process indicators: Gravity: 121°C/250 F- 30 minutes (wrapped/porous) Pre-vacuum: 132°C/270 F- 3 minutes (unwrapped/nonporous) Pre-vacuum: 132°C/270 F- 4 minutes (wrapped/porous) Pre-vacuum: 134°C/273 F- 4 minutes (wrapped/porous) Pre-vacuum: 135°C/275 F- 3 minutes (wrapped/porous and unwrapped/nonporous, mixed load)

Source page: https://510kreport.com/device/K220778
Methodology: https://510kreport.com/methodology