510(k) · Cleared
ClearedEO Chex Indicator Tape
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 Jun 12, 2024 as substantially equivalent to K002861 (Steritec Products, Inc., 2000) after a 71-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jun 12, 2024
- Review
- 71 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002861 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK002861 EO Gas Sterilization Process Indicator Tapes, Model CI 124Steritec Products, Inc. · 2000
- This deviceK240910 EO Chex Indicator TapePropper Manufacturing Co., Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002861 | EO Gas Sterilization Process Indicator Tapes, Model CI 124 | Steritec Products, Inc. | 2000 | — |
| 0 (this device) | K240910 | EO Chex Indicator Tape | Propper Manufacturing Co., Inc. | 2024 | — |
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 |
|---|---|---|---|
| * | K002861 | EO Gas Sterilization Process Indicator Tapes, Model CI 124Summary page 6…the subject device (EO Chex™ Indicator Tape, Propper Manufacturing Co., Inc.) to Predicate device EO Gas Sterilization Process Indicator Tapes, SteriTec Products, Inc., K002861. Parameter Subject Device Predicate Device, K002861 Comparison… | 2000 |
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 no recall.
- 1 other device also cites its predicate K002861.
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. 2024, 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 EO Chex Indicator Tape for Ethylene Oxide gas sterilization is designed to secure wrapped packs by a health care provider. EO Chex indicator tape demonstrates that the packs have been exposed to an EO gas sterilization process, and to distinguish between processed and unprocessed packs. The EO process indicator turns from pink to orange-brown when exposed to EO gas sterilization conditions, thus providing an indication of processed items. The EO Chex…
Read the full statement (176 words)
The EO Chex Indicator Tape for Ethylene Oxide gas sterilization is designed to secure wrapped packs by a health care provider. EO Chex indicator tape demonstrates that the packs have been exposed to an EO gas sterilization process, and to distinguish between processed and unprocessed packs. The EO process indicator turns from pink to orange-brown when exposed to EO gas sterilization conditions, thus providing an indication of processed items.
The EO Chex indicator tape can be used in the following EO sterilization cycles:
1. 38°C, 736 mg/L EO, 40-80% RH, 4.5 hours exposure
2. 38°C, 759 mg/ L EO, 40-80% RH, 4.5 hours exposure
3. 54°C, 600 mg/ L EO, 40-60% RH, 45 min or longer
4. 55°C, 736 mg/ L EO, 40-80% RH, 1 hour exposure
5. 55°C, 759 mg/ L EO, 40-80% RH, 1 hour exposure
Performance
The performance of the EO Chex indicator tape meets the requirements of ANSI/AAMI/ISO 11140-1:2014 for Type 1 process indicators.
Stated Values
Temperature: 37°C, RH: 60%, Time: 25min, EO: 600mg/L
Temperature: 54°C, RH: 60%, Time: 20min, EO: 600mg/L
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240910 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240910: EO Chex Indicator Tape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240910
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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