510(k) · Cleared
ClearedSpsmedical Airview Bowie Dick Test Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spsmedical Supply Corp. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Jun 25, 2004 as substantially equivalent to K841168 (Parke-Davis Co., 1984) after a 66-day review. Its family tree reaches back 1 generation to 1984. 2 later devices descend from it.
- Decided
- Jun 25, 2004
- Review
- 66 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K841168 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK841168 Sterilization Process IndicatorParke-Davis Co. · 1984
- This deviceK041017 Spsmedical Airview Bowie Dick Test PackSpsmedical Supply Corp. · 2004
- Descendant · cites it directly · 1 of its ownK130211 Airview Bowie Dick; Test Pack, Indicator SheetsSpsmedical Supply Corp. · 2013
- Descendant · 2 generations on · 0 of its ownK133204 Airview Mini Owie Dick Test PackCrosstex International · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K841168 | Sterilization Process Indicator | Parke-Davis Co. | 1984 | — |
| 0 (this device) | K041017 | Spsmedical Airview Bowie Dick Test Pack | Spsmedical Supply Corp. | 2004 | — |
| +1 | K130211 | Airview Bowie Dick; Test Pack, Indicator Sheets | Spsmedical Supply Corp. | 2013 | — |
| +2 | K133204 | Airview Mini Owie Dick Test Pack | Crosstex International | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K841168 | Sterilization Process IndicatorSummary page 1…80105 Predicate Device: 3M Comply Bowie & Dick Test Pack 5 10(k) no. 841168 - 13 - Device Description The SPSmedical AirViewiM Bowie Dick T… | 1984 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130211 | Airview Bowie Dick; Test Pack, Indicator Sheets | 2013 | 1 |
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?
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?
The SPSmedical AirView Bowie Dick Test Pack and AirView Bowie Dick indicator sheets are designed to detect the presence of residual air in pre-vacuum steam sterilizers. When tested in a pre-vacuum sterilizer operating at 134°C the indicator will demonstrate a uniform color change from cream or blue to dark brown/black when proper sterilization conditions have been met and no air is detected. It is designed to be used for daily Bowie Dick testing of steam sterilizers as described in AAMI/ANSI ST-46.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041017 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041017: Spsmedical Airview Bowie Dick Test Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041017
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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