510(k) · Cleared
Cleared3M Attest 293 Auto-Reader, 3M Attest 293G 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 16, 2005 as substantially equivalent to K004009 (3M Company, 2002) and 1 other predicate after an 11-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Aug 16, 2005
- Review
- 11 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K004009 (2002). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK004009 3M Attest 290 Auto-Reader3M Company · 2002
- This deviceK052128 3M Attest 293 Auto-Reader, 3M Attest 293G Auto-Reader3M Company · 2005
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) | K052128 | 3M Attest 293 Auto-Reader, 3M Attest 293G Auto-Reader | 3M Company | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 2…f these initial premarket notifications (K900771) and (K926364) listed the 3M Attest 190 Auto-reader as an accessory, subsequently the Model 290 Auto-reader was cleared (K004009) for use with these BIs and serves as the predicate device for the new Model 293 Auto-reader. The Attest 293 is comprised of thr… | 2002 |
| * | K031012 | Attest Rapid Readout Biological Indicator for EO, Model 1294; Attest Rapid Readout…Summary page 2…ncubated at 37 °C. The purpose of these BIs is to assess whether a potential failure of an ethylene oxide sterilization cycle has occurred. The model 290G was cleared (K031012) with the Attest 1294 BI and serves as the predicate for the 293G. The Attest 293G is compdsed of three (3) Attest 290G units w… | 2003 |
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.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K004009.
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 293 Auto-reader is designed to incubate and automatically read the 3M Attest 1291 and/or 3M Attest 1292 Rapid Readout Biological Indicators for Steam, at 60°C for a final negative fluorescence reading at 1 hour for Attest 1291 or 3 hours for Attest 1292. The 3M Attest 293 Auto-reader is also designed to allow for further incubation of the Attest 1291 and/or Attest 1292 Rapid Readout Biological Indicators for Steam, for a final negative…
Read the full statement (130 words)
The 3M Attest 293 Auto-reader is designed to incubate and automatically read the 3M Attest 1291 and/or 3M Attest 1292 Rapid Readout Biological Indicators for Steam, at 60°C for a final negative fluorescence reading at 1 hour for Attest 1291 or 3 hours for Attest 1292.
The 3M Attest 293 Auto-reader is also designed to allow for further incubation of the Attest 1291 and/or Attest 1292 Rapid Readout Biological Indicators for Steam, for a final negative, visual pH color change of the growth media at 24 hours for Attest 1291 and 48 hours for Attest 1292.
The 3M Attest 293G Auto-reader is designed to incubate and automatically read the 3M Attest 1294 Rapid Readout Biological Indicators (RRBI) for EO, at 37°C for a final negative fluorescence reading at 4 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052128: 3M Attest 293 Auto-Reader, 3M Attest 293G 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/K052128
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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