510(k) · Cleared
ClearedSterrad Chemical Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Medical, Inc. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Oct 4, 1993 after a 529-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 42 later devices descend from it.
- Decided
- Oct 4, 1993
- Review
- 529 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 0
42 later devices descend from it, 5 citing it directly.
- This deviceK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
- Descendant · cites it directly · 15 of its ownK103210 Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad…Advanced Sterilization Products · 2011
- Descendant · cites it directly · 14 of its ownK013228 3M Comply 1248 Gas Plasma Chemical IndicatorMinnesota Mining and Mfg. Co. · 2002 · Recalled
- Descendant · 2 generations on · 13 of its ownK150622 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2015
- Descendant · 3 generations on · 12 of its ownK170321 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2017
- Descendant · 4 generations on · 11 of its ownK183211 3M Comply Hydrogen Peroxide Chemical Indicator3M Company · 2019
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K103210Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with…Advanced Sterilization Products · 2011 · cites it directly15descendants
- K0132283M Comply 1248 Gas Plasma Chemical IndicatorMinnesota Mining and Mfg. Co. · 2002 · cites it directly14descendants
- K1506223M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2015 · 2 generations on13descendants
- K1703213M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2017 · 3 generations on12descendants
- K1832113M Comply Hydrogen Peroxide Chemical Indicator3M Company · 2019 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921910 | Sterrad Chemical Indicator | Johnson & Johnson Medical, Inc. | 1993 | — |
| +1 | K103210 | Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek… | Advanced Sterilization Products | 2011 | — |
| +1 | K013228 | 3M Comply 1248 Gas Plasma Chemical Indicator | Minnesota Mining and Mfg. Co. | 2002 | 1 |
| +2 | K150622 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2015 | — |
| +3 | K170321 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2017 | — |
| +4 | K183211 | 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 7 | 0 |
| 2024 | 5 | 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? (42)
See all 425 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103210 | Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with… | 2011 | 15 |
| K013228 | 3M Comply 1248 Gas Plasma Chemical Indicator | 2002 | 14 |
| K030680 | Spsmedical Gas Plasma Chemical Indicator | 2003 | 6 |
| K103218 | Sterrad Chemical Indicator Strip | 2011 | 2 |
| K972300 | Cross-Checks P | 1998 | 0 |
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, K103210 (Advanced Sterilization Products, 2011) has gone furthest, with 15 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/K921910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K921910: Sterrad Chemical Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921910
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026