510(k) · Cleared
ClearedSteritec Cross-Checks EO Gas Sterilization Integrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steritec Products Mfg Co, Inc. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Oct 8, 1998 as substantially equivalent to K800029 (Surgicot, Inc., 1980) after a 79-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- Oct 8, 1998
- Review
- 79 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K800029 (1980). No later device cites it as a predicate yet.
- Root · 1 generation backK800029 Surgicot 2 Indicator SystemSurgicot, Inc. · 1980
- This deviceK982547 Steritec Cross-Checks EO Gas Sterilization IntegratorSteritec Products Mfg Co, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K800029 | Surgicot 2 Indicator System | Surgicot, Inc. | 1980 | — |
| 0 (this device) | K982547 | Steritec Cross-Checks EO Gas Sterilization Integrator | Steritec Products Mfg Co, Inc. | 1998 | — |
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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K800029 | Surgicot 2 Indicator SystemSummary page 2…t in construction and performance to the predicate device. Since it is equivalent in construction and performance to the SURGICOT 2 EO Gas Indicator Strip, (FDA 510(k) # K800029 and K800029A) manufactured by SURGICOT of Research Triangle Park, North Carolina (Predicate device), it will perform in the same… | 1980 |
| Kept off the family tree | K800029A | SURGICOT 2 EO Gas Indicator Strip Number could not be read Summary page 2…t in construction and performance to the predicate device. Since it is equivalent in construction and performance to the SURGICOT 2 EO Gas Indicator Strip, (FDA 510(k) # K800029 and K800029A) manufactured by SURGICOT of Research Triangle Park, North Carolina (Predicate device), it will perform in the same sa… |
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.
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 | — |
What is it indicated for?
Steritec Cross-Checks EO Integrators are designed to provide an integrated response to EO gas sterilization in hospital sterilizers. Color change to brown is complete between 30 and 45 minutes exposure to EO gas mixture of 88/12 with gas concentration of 600 mg/L, temperature at 130 F and Relative Humidity at 45%.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982547: Steritec Cross-Checks EO Gas Sterilization Integrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982547
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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