510(k) · Cleared
ClearedAttest Rapid Readout Biological Indicator for EO, Model 1294; Attest Rapid Readout Biological Indicator for EO Test Pack
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 Oct 16, 2003 after a 199-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Oct 16, 2003
- Review
- 199 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK031012 Attest Rapid Readout Biological Indicator for EO, Model 1294; Attest…3M Company · 2003
- Descendant · cites it directly · 7 of its ownK123546 3M Attest (TM) Auto-Reader3M Company · 2013 · Recalled
- Descendant · 2 generations on · 6 of its ownK171587 VERIFY Incubator for Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation · 2017
- Descendant · 3 generations on · 4 of its ownK190297 Celerity HP IncubatorSTERIS Corporation · 2019
- Descendant · 4 generations on · 3 of its ownK213881 Celerity IncubatorSTERIS Corporation · 2022
- Descendant · 5 generations on · 2 of its ownK223715 Celerity IncubatorSTERIS Corporation · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K1235463M Attest (TM) Auto-Reader3M Company · 2013 · cites it directly7descendants
- K171587VERIFY Incubator for Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation · 2017 · 2 generations on6descendants
- K190297Celerity HP IncubatorSTERIS Corporation · 2019 · 3 generations on4descendants
- K213881Celerity IncubatorSTERIS Corporation · 2022 · 4 generations on3descendants
- K223715Celerity IncubatorSTERIS Corporation · 2023 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031012 | Attest Rapid Readout Biological Indicator for EO, Model 1294; Attest Rapid… | 3M Company | 2003 | — |
| +1 | K123546 | 3M Attest (TM) Auto-Reader | 3M Company | 2013 | 1 |
| +2 | K171587 | VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation | 2017 | — |
| +3 | K190297 | Celerity HP Incubator | STERIS Corporation | 2019 | — |
| +4 | K213881 | Celerity Incubator | STERIS Corporation | 2022 | — |
| +5 | K223715 | Celerity Incubator | STERIS Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 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? (2)
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 |
|---|---|---|---|
| * | — | Steris Verify Named without a submission number | |
| * | — | 3M Attest 1292 Rapid Readout Biological Indicator for Steam Named without a submission number |
What descends from it? (9)
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, K123546 (3M Company, 2013) has gone furthest, with 7 descendants of its own.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The 3M Attest 1294 Rapid Readout Biological Indicator for EO is used to monitor ethylene oxide sterilization cycles when used in conjunction with the 3M Attest 290G Auto-reader.
The 3M Attest 1298 Rapid Readout Biological Indicator for EO Test Pack is a routine challenge pack used to monitor ethylene oxide sterilization cycles when used in conjunction with the 3M Attest 290G Auto-reader.
The 3M Attest 290G Auto-reader is designed to incubate and automatically read the 3M Attest 1294 Rapid Readout Biological Indicators (RRBI) for EO at 37% for a final negative fluorescence reading at 4 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031012: Attest Rapid Readout Biological Indicator for EO, Model 1294; Attest Rapid Readout Biological Indicator for EO Test Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031012
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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