510(k) · Cleared
ClearedSterilization Process Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parke-Davis Co. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on May 9, 1984 after a 51-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
- May 9, 1984
- Review
- 51 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK841168 Sterilization Process IndicatorParke-Davis Co. · 1984
- Descendant · cites it directly · 2 of its ownK041017 Spsmedical Airview Bowie Dick Test PackSpsmedical Supply Corp. · 2004
- Descendant · 2 generations on · 1 of its ownK130211 Airview Bowie Dick; Test Pack, Indicator SheetsSpsmedical Supply Corp. · 2013
- Descendant · cites it directly · 1 of its ownK093199 3M Comply Bowie- Dick Type Lead Free Test Pack3M Company · 2009
- Descendant · 2 generations on · 0 of its ownK143629 U&U Bowie-Dick Test PackU&U Medical Technology Co, Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK133204 Airview Mini Owie Dick Test PackCrosstex International · 2014
Most influential descendants
Showing 5 of 5 · See all- K041017Spsmedical Airview Bowie Dick Test PackSpsmedical Supply Corp. · 2004 · cites it directly2descendants
- K130211Airview Bowie Dick; Test Pack, Indicator SheetsSpsmedical Supply Corp. · 2013 · 2 generations on1descendant
- K0931993M Comply Bowie- Dick Type Lead Free Test Pack3M Company · 2009 · cites it directly1descendant
- K143629U&U Bowie-Dick Test PackU&U Medical Technology Co, Ltd. · 2015 · 2 generations on0descendants
- K133204Airview Mini Owie Dick Test PackCrosstex International · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K841168 | Sterilization Process Indicator | Parke-Davis Co. | 1984 | — |
| +1 | K041017 | Spsmedical Airview Bowie Dick Test Pack | Spsmedical Supply Corp. | 2004 | — |
| +2 | K130211 | Airview Bowie Dick; Test Pack, Indicator Sheets | Spsmedical Supply Corp. | 2013 | — |
| +1 | K093199 | 3M Comply Bowie- Dick Type Lead Free Test Pack | 3M Company | 2009 | — |
| +2 | K143629 | U&U Bowie-Dick Test Pack | U&U Medical Technology Co, Ltd. | 2015 | — |
| +3 | K133204 | Airview Mini Owie Dick Test Pack | Crosstex International | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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)
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, K041017 (Spsmedical Supply Corp., 2004) 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/K841168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K841168: Sterilization Process Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K841168
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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