De Novo · Granted
Granted3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · JOJ Indicator, Physical/Chemical Sterilization Process
Granted on May 21, 2024 as a new device type through De Novo after a 235-day review.
- Decided
- May 21, 2024
- Review
- 235 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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.
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. 2024, this device’s year, is highlighted.
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?
3M™ Attest eBowie Dick Test Card and 3M™ Attest eBowie-Dick Card Holder As a Sterilizer Monitoring Device, the 3M™ Attest™ eBowie-Dick Test Card 10135 and 3M™ Attest™ eBowie-Dick Card Holder 10135CH is used in conjunction with the 3M™ Attest™ eBowie-Dick Auto-reader 1190 to monitor the equipment performance of steam sterilizers each day, as well as after a steam sterilizer repair. The 3M™ Attest™ eBowie-Dick Test Card 10135 will detect steam penetration…
Read the full statement (153 words)
3M™ Attest eBowie Dick Test Card and 3M™ Attest eBowie-Dick Card Holder
As a Sterilizer Monitoring Device, the 3M™ Attest™ eBowie-Dick Test Card 10135 and 3M™ Attest™ eBowie-Dick Card Holder 10135CH is used in conjunction with the 3M™ Attest™ eBowie-Dick Auto-reader 1190 to monitor the equipment performance of steam sterilizers each day, as well as after a steam sterilizer repair. The 3M™ Attest™ eBowie-Dick Test Card 10135 will detect steam penetration as a means of measuring air removal efficiency. The 3M™ Attest™ eBowie-Dick Test Card 10135 and 3M™ Attest™ eBowie-Dick Card Holder 10135CH is designed for testing air removal efficiency of 132°C (270°F), 134°C (273°F), and 135°C (275°F) for 3.5 minute test cycles in dynamic-air-removal steam sterilizers with chamber volumes greater than 54L (approximately 2 cubic feet).
3M™ Attest eBowie-Dick Auto-reader
The 3M™ Attest™ eBowie-Dick Auto-reader is designed to automatically interpret, store, and display the result of the 3M™ Attest™ eBowie-Dick Test Card.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230068 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230068: 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230068
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026