510(k) · Cleared
ClearedTST Control Integrator for Steam Autoclave
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Board of Directors, Albert Browne, Ltd. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Nov 1, 1990 after a 119-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Nov 1, 1990
- Review
- 119 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK902958 TST Control Integrator for Steam AutoclaveBoard of Directors, Albert Browne, Ltd. · 1990
- Descendant · cites it directly · 2 of its ownK071895 Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorSTERIS Corporation · 2007
- Descendant · cites it directly · 1 of its ownK965154 TST Control Integrator for Steam AutoclaveAlbert Browne, Ltd. · 1997
- Descendant · 2 generations on · 0 of its ownK162758 VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators…STERIS Corporation · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK102894 Classix Chemical Sterilization IndicatorPropper Mfg. Co., Inc. · 2011
- Descendant · cites it directly · 0 of its ownK062651 Prochem Ext Chemical IntegratorRaven Biological Laboratories, Inc. · 2007
Most influential descendants
Showing 5 of 5 · See all- K071895Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 IndicatorSTERIS Corporation · 2007 · cites it directly2descendants
- K965154TST Control Integrator for Steam AutoclaveAlbert Browne, Ltd. · 1997 · cites it directly1descendant
- K162758VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test…STERIS Corporation · 2017 · 2 generations on0descendants
- K102894Classix Chemical Sterilization IndicatorPropper Mfg. Co., Inc. · 2011 · 2 generations on0descendants
- K062651Prochem Ext Chemical IntegratorRaven Biological Laboratories, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K902958 | TST Control Integrator for Steam Autoclave | Board of Directors, Albert Browne, Ltd. | 1990 | — |
| +1 | K071895 | Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator | STERIS Corporation | 2007 | — |
| +1 | K965154 | TST Control Integrator for Steam Autoclave | Albert Browne, Ltd. | 1997 | — |
| +2 | K162758 | VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie… | STERIS Corporation | 2017 | 1 |
| +2 | K102894 | Classix Chemical Sterilization Indicator | Propper Mfg. Co., Inc. | 2011 | — |
| +1 | K062651 | Prochem Ext Chemical Integrator | Raven Biological Laboratories, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 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, K071895 (STERIS Corporation, 2007) has gone furthest, with 2 descendants 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/K902958 · printed Nov 6, 2026
Cite this page
510(k) Report. “K902958: TST Control Integrator for Steam Autoclave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902958
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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