510(k) · Cleared
ClearedEO Gas Sterilization Process Indicator Tapes, Model CI 124
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steritec Products, Inc. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Nov 29, 2000 after a 77-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Nov 29, 2000
- Review
- 77 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK002861 EO Gas Sterilization Process Indicator Tapes, Model CI 124Steritec Products, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK210866 Steri-Dot Process IndicatorPropper Manufacturing Co., Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK241036 Autoclave Indicator Tape; EO Indicator TapeJiangmen New Era External Use Drug Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK240910 EO Chex Indicator TapePropper Manufacturing Co., Inc. · 2024
Most influential descendants
Showing 3 of 3 · See all- K210866Steri-Dot Process IndicatorPropper Manufacturing Co., Inc. · 2021 · cites it directly1descendant
- K241036Autoclave Indicator Tape; EO Indicator TapeJiangmen New Era External Use Drug Co., Ltd. · 2024 · 2 generations on0descendants
- K240910EO Chex Indicator TapePropper Manufacturing Co., Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002861 | EO Gas Sterilization Process Indicator Tapes, Model CI 124 | Steritec Products, Inc. | 2000 | — |
| +1 | K210866 | Steri-Dot Process Indicator | Propper Manufacturing Co., Inc. | 2021 | — |
| +2 | K241036 | Autoclave Indicator Tape; EO Indicator Tape | Jiangmen New Era External Use Drug Co., Ltd. | 2024 | — |
| +1 | K240910 | EO Chex Indicator Tape | Propper Manufacturing Co., Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K210866 (Propper Manufacturing Co., Inc., 2021) has gone furthest, with 1 descendant of its own.
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.
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 | — |
https://510kreport.com/device/K002861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002861: EO Gas Sterilization Process Indicator Tapes, Model CI 124.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002861
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026