510(k) · Cleared
ClearedGas-Chex Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Propper Manufacturing Co., Inc. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Jan 20, 2022 as substantially equivalent to K191021 (Terragene S.A., 2019) after a 157-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Jan 20, 2022
- Review
- 157 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K191021 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backK191021 Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene…Terragene S.A. · 2019 · Recalled
- This deviceK212592 Gas-Chex IndicatorPropper Manufacturing Co., Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape… | Terragene S.A. | 2019 | 1 |
| 0 (this device) | K212592 | Gas-Chex Indicator | Propper Manufacturing Co., Inc. | 2022 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JOJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JOJ device
- #1 K261992 3M™ Attest™ Steam Chemical Integrator (1243A…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene…Summary page 5…Comparison to Legally Marketed Predicate Device Comparison of the subject device (Gas-Chex Indicator, Propper Manufacturing Co., Inc) to Predicate device (Integron IT12, k191021, by Terragene S.A.). Subject device Predicate device Comparison Pro… | 2019 |
| † | K972747 | BI-O.K. EO Gas Biological Test-Pak (269305,269310,269320) | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 5 other devices also cite its predicate K191021.
How does its category compare?
All JOJ devicesJOJ Indicator, Physical/Chemical Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · JOJ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOJ
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOJ
12in 2025
MAUDE reports naming product code JOJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 140 | 0 | 1 |
| 2008 | 9 | 57 | 2 | 1 |
| 2009 | 7 | 188 | 2 | 9 |
| 2010 | 6 | 115 | 0 | 3 |
| 2011 | 13 | 151 | 2 | 1 |
| 2012 | 7 | 224 | 0 | 8 |
| 2013 | 6 | 212 | 0 | 6 |
| 2014 | 6 | 198 | 0 | 11 |
| 2015 | 8 | 188 | 0 | 7 |
| 2016 | 4 | 150 | 0 | 11 |
| 2017 | 7 | 172 | 0 | 35 |
| 2018 | 5 | 150 | 0 | 12 |
| 2019 | 12 | 38 | 0 | 8 |
| 2020 | 7 | 108 | 0 | 6 |
| 2021 | 4 | 87 | 1 | 29 |
| 2022 | 8 | 90 | 0 | 23 |
| 2023 | 4 | 53 | 1 | 39 |
| 2024 | 12 | 71 | 0 | 25 |
| 2025 | 6 | 90 | 0 | 12 |
| 2026 | 3 | 30 | 0 | — |
What is it indicated for?
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…
Read the full statement (197 words)
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%
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212592: Gas-Chex Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212592
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026