510(k) · Cleared
Recalled · Class II · 20143M Attest (TM) 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 Mar 18, 2013 as substantially equivalent to K004009 (3M Company, 2002) and 1 other predicate after a 119-day review. Its family tree reaches back 1 generation to 2002. 7 later devices descend from it. It has been recalled once.
- Decided
- Mar 18, 2013
- Review
- 119 days
- Class
- Class II
- Product code
- FRC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K004009 (2002). 2 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK004009 3M Attest 290 Auto-Reader3M Company · 2002
- This deviceK123546 3M Attest (TM) Auto-Reader3M Company · 2013
- Descendant · cites it directly · 6 of its ownK171587 VERIFY Incubator for Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation · 2017
- Descendant · 2 generations on · 4 of its ownK190297 Celerity HP IncubatorSTERIS Corporation · 2019
- Descendant · 3 generations on · 3 of its ownK213881 Celerity IncubatorSTERIS Corporation · 2022
- Descendant · 4 generations on · 2 of its ownK223715 Celerity IncubatorSTERIS Corporation · 2023
- Descendant · 5 generations on · 0 of its ownK250061 Celerity IncubatorSTERIS Corporation · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K171587VERIFY Incubator for Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation · 2017 · cites it directly6descendants
- K190297Celerity HP IncubatorSTERIS Corporation · 2019 · 2 generations on4descendants
- K213881Celerity IncubatorSTERIS Corporation · 2022 · 3 generations on3descendants
- K223715Celerity IncubatorSTERIS Corporation · 2023 · 4 generations on2descendants
- K250061Celerity IncubatorSTERIS Corporation · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K004009 | 3M Attest 290 Auto-Reader | 3M Company | 2002 | — |
| 0 (this device) | K123546 | 3M Attest (TM) Auto-Reader | 3M Company | 2013 | — |
| +1 | K171587 | VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation | 2017 | — |
| +2 | K190297 | Celerity HP Incubator | STERIS Corporation | 2019 | — |
| +3 | K213881 | Celerity Incubator | STERIS Corporation | 2022 | — |
| +4 | K223715 | Celerity Incubator | STERIS Corporation | 2023 | — |
| +5 | K250061 | Celerity Incubator | STERIS Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K004009 | 3M Attest 290 Auto-ReaderSummary page 1…r in design to AttestTM 490 for Use as AttestTm 290 Auto-reader Auto-reader ([(103277, K12 1484) (K004009) AtteStTM 390G Auto-reader Same Intended Use and Indications Similar in design to Attestm 490… | 2002 |
| * | K031012 | Attest Rapid Readout Biological Indicator for EO, Model 1294; Attest Rapid Readout…Summary page 1…ign to Attestm 490 for Use as Atest Tm 290G Auto- Auto-reader ([K103277, [K12 1484) ____________________reader ([031012) Description of Device: The AttestTM 390 and 390G Auto-readers are used in conjunction with AttestTM Rapid Reado… | 2003 |
| † | K103277 | 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-Reader | 2011 |
| † | K121484 | 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM) Auto-Reader | 2012 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171587 | VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator | 2017 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 9, 2014 | Class II | Z-2002-2014 | Labeling Change Control | Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product contains dry natural rubber" as required by the United States Food and Drug Administration (FDA) for medical devices. The non-slip pads at the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The 3M Attest 390 Auto-reader is designed to incubate and automatically read the 3M Attest Rapid Readout Biological Indicators for Steam, 1291 and 1292, at 60'C for a final fluorescent result at 1 hour for 1291 and 3 hours for 1292.
The 3M Attest 390G Auto-reader is designed to incubate and automatically read the 3M Attest Rapid Readout Biological Indicator for Ethylene Oxide, 1294, at 37 0 C for a final fluorescent result at 4 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123546 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123546: 3M Attest (TM) Auto-Reader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123546
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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