# K212592: Gas-Chex Indicator

- Pathway: 510(k) (Abbreviated)
- Applicant: Propper Manufacturing Co., Inc.
- Decided: Jan 20, 2022 after 157 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: 1 generation back to K191021 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191021: Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye, Terragene S.A. (2019) Summary page 5.

## Indications for use
The Gas-Chex Indicator is an integrating indicator designed to respond to all critical parameters over a specified range of Ethylene Oxide sterilization cycles. The Gas-Chex Indicator is intended to be placed in each pack, pouch, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: 1. 37° C, 736 mg/1 EO, ≥35% RH, 3 hours exposure 2. 37° C, 759 mg/1 EO, ≥35% RH, 3 hours exposure 3. 38° C, 736 mg/1 EO, 40-80% RH, 4.5 hours exposure 4. 38° C, 759 mg/1 EO, 40-80% RH, 4.5 hours exposure 5. 55° C, 736 mg/1 EO, ≥35% RH, 1 hour exposure 6. 55° C, 759 mg/1 EO, ≥35% RH, 1 hour exposure 7. 55° C, 600 mg/1 EO, 60% RH, 4 hours exposure The Gas-Chex Indicator for EO sterilization has the following minimum Stated Values determined in a Resistometer: 54 °C, 42 min, EO 600 mg/1, RH 60± 10% 37°C, 75 min, EO 600 mg/1, RH 60±10% 55°C, 36 min, EO 736 mg/1, RH 50±10% 37°C, 75 min, EO 736 mg/1, RH 50±10% 55°C, 35 min, EO 759 mg/1, RH 50±10% 37°C, 75 min, EO 759 mg/1, RH 50±10%

Source page: https://510kreport.com/device/K212592
Methodology: https://510kreport.com/methodology