510(k) · Cleared
Cleared3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · FRC Indicator, Biological Sterilization Process
Cleared on Aug 13, 2014 as substantially equivalent to K123017 (Advanced Sterilization Products, 2012) and 2 other predicates after a 180-day review. Its family tree reaches back 6 generations to 2002. 12 later devices descend from it.
- Decided
- Aug 13, 2014
- Review
- 180 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K994055 (2002). 13 ancestors in all, the oldest K900771 (1990). 12 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
- 5 generations backK031226 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2003 · Recalled
- 4 generations backK071014 Modification to Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2007
- 3 generations backK102884 Sterrad Cyclesure 24 Biological IndicatorAdvanced Sterilization Products · 2011
- 2 generations backK111375 Sterrad (R) Cyclesure (R) 24 Biological IndicatorAdvanced Sterilization Products · 2012
- 1 generation backK123017 Sterrad Cyclesure 24 Biological Indicator Model 14324Advanced Sterilization Products · 2012
- This deviceK140392 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company · 2014
- Descendant · cites it directly · 11 of its ownK152060 3M Attest Rapid Readout Biological Indicator 12953M Company · 2015
- Descendant · 2 generations on · 6 of its ownK160546 3M Attest Rapid Readout Biological Indicator3M Company · 2016
- Descendant · cites it directly · 5 of its ownK171003 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader3M Company · 2017
- Descendant · 2 generations on · 4 of its ownK173435 3M Attest Rapid Readout Biological Indicator3M Company · 2018
- Descendant · 3 generations on · 3 of its ownK200996 3M Attest Rapid Readout Biological Indicator3M Company · 2020
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K1520603M Attest Rapid Readout Biological Indicator 12953M Company · 2015 · cites it directly11descendants
- K1605463M Attest Rapid Readout Biological Indicator3M Company · 2016 · 2 generations on6descendants
- K1710033M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader3M Company · 2017 · cites it directly5descendants
- K1734353M Attest Rapid Readout Biological Indicator3M Company · 2018 · 2 generations on4descendants
- K2009963M Attest Rapid Readout Biological Indicator3M Company · 2020 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K994055 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2002 | 1 |
| −5 | K031226 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2003 | 1 |
| −4 | K071014 | Modification to Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2007 | — |
| −3 | K102884 | Sterrad Cyclesure 24 Biological Indicator | Advanced Sterilization Products | 2011 | — |
| −2 | K111375 | Sterrad (R) Cyclesure (R) 24 Biological Indicator | Advanced Sterilization Products | 2012 | — |
| −1 | K123017 | Sterrad Cyclesure 24 Biological Indicator Model 14324 | Advanced Sterilization Products | 2012 | — |
| 0 (this device) | K140392 | 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader | 3M Company | 2014 | — |
| +1 | K152060 | 3M Attest Rapid Readout Biological Indicator 1295 | 3M Company | 2015 | — |
| +2 | K160546 | 3M Attest Rapid Readout Biological Indicator | 3M Company | 2016 | — |
| +1 | K171003 | 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader | 3M Company | 2017 | — |
| +2 | K173435 | 3M Attest Rapid Readout Biological Indicator | 3M Company | 2018 | — |
| +3 | K200996 | 3M Attest Rapid Readout Biological Indicator | 3M Company | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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 FRC? 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 FRC device
- #1 K250044 Celerity 5 HP Biological Indicator (LCB052)…score 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K123017 | Sterrad Cyclesure 24 Biological Indicator Model 14324Summary page 5…Predicate ‘Intended Use Predicate’ – shares same Intended Use as Attest™ 1295 Rapid STERRAD® CycleSure® 24 BI, K123017 Readout BI ‘Design Predicate’ – shares same BI design as Attest™ 1492V Sup… | 2012 |
| * | K121484 | 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM) Auto-ReaderSummary page 5…ure® 24 BI, K123017 Readout BI ‘Design Predicate’ – shares same BI design as Attest™ 1492V Super Rapid Readout BI, K121484 3M Attest™ Auto- 3M Attest™ Auto-reader 490, K121484 reader 490H === Page… | 2012 |
| * | K103277 | 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-ReaderSummary page 6…™ Auto-reader 490H is similar in design to the Attest™ Auto-reader 490 that has been cleared for use with the Attest™ 1491 Super Rapid Readout Biological Indicator under K103277 and Attest™ 1492V Super Rapid Readout Biological Indicator under K121484. The Attest™ Auto-reader 490H is designed to incubate a… | 2011 |
What descends from it? (12)
See all 123 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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K152060 (3M Company, 2015) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K123017.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FRC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRC
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRC
8so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRC
9in 2025
MAUDE reports naming product code FRC, 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 | 3 | 83 | 0 | 100 |
| 2008 | 1 | — | 0 | 60 |
| 2009 | 6 | 183 | 1 | 45 |
| 2010 | 4 | 165 | 0 | 57 |
| 2011 | 6 | 118 | 0 | 37 |
| 2012 | 9 | 178 | 2 | 46 |
| 2013 | 4 | 260 | 2 | 39 |
| 2014 | 13 | 174 | 0 | 51 |
| 2015 | 3 | 130 | 0 | 182 |
| 2016 | 2 | — | 0 | 482 |
| 2017 | 10 | 130 | 0 | 182 |
| 2018 | 18 | 97 | 0 | 22 |
| 2019 | 5 | 88 | 0 | 30 |
| 2020 | 10 | 150 | 0 | 16 |
| 2021 | 5 | 107 | 0 | 10 |
| 2022 | 5 | 193 | 4 | 9 |
| 2023 | 6 | 190 | 1 | 20 |
| 2024 | 8 | 105 | 0 | 22 |
| 2025 | 6 | 29 | 0 | 9 |
| 2026 | 1 | — | 8 | — |
What is it indicated for?
Use the 3M Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M Attest™ Auto-reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in STERRAD® NX and 100NX systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140392: 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140392
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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