510(k) · Cleared
Cleared3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini 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 Apr 6, 2022 as substantially equivalent to K192550 (3M Company, 2020) after a 121-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.
- Decided
- Apr 6, 2022
- Review
- 121 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K926364 (1995). 11 ancestors in all, the oldest K900771 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK926364 Attest Brand Rapid Readout Biological Ind. #129X3M Health Care, Ltd. · 1995
- 5 generations backK090569 Modification to: Attest Rapid Readout Biological Indicator, Mode 12923M Company · 2009
- 4 generations backK121484 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest…3M Company · 2012
- 3 generations backK121593 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest…3M Company · 2013
- 2 generations backK173519 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super…3M Company · 2018 · Recalled
- 1 generation backK192550 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM…3M Company · 2020
- This deviceK213809 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super…3M Company · 2022
- Descendant · cites it directly · 0 of its ownK242538 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™…3M Company · 2024
Most influential descendants
Showing 1 of 1 · See all- K2425383M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam…3M Company · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K926364 | Attest Brand Rapid Readout Biological Ind. #129X | 3M Health Care, Ltd. | 1995 | — |
| −5 | K090569 | Modification to: Attest Rapid Readout Biological Indicator, Mode 1292 | 3M Company | 2009 | — |
| −4 | K121484 | 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM)… | 3M Company | 2012 | — |
| −3 | K121593 | 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super… | 3M Company | 2013 | — |
| −2 | K173519 | 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5… | 3M Company | 2018 | 1 |
| −1 | K192550 | 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super… | 3M Company | 2020 | — |
| 0 (this device) | K213809 | 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam… | 3M Company | 2022 | — |
| +1 | K242538 | 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super… | 3M Company | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (1)
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 |
|---|---|---|---|
| * | K192550 | 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid…Summary page 6…™ Attest™ Super Rapid Steam Biological Indicator 1592, 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, 3M™ Attest™ Auto-reader 490, and 3M™ Attest™ Auto-reader 490H, K192550 Reference Device: 3M™ Attest™ Mini Auto-reader 490M, K200092 Indications for Use – 1592 Biological Indicator Use the 3M™ Attes… | 2020 |
| † | K200092 | 3MTM AttestTM Mini Auto-reader 490M | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242538 | 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam… | 2024 | 0 |
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 27 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K242538 (3M Company, 2024) has gone furthest, with 0 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. 2022, 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?
3M™ Attest™ Super Rapid Steam Biological Indicator 1592: Use the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3SM™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles: Cycle Type | Exposure Temperature | Exposure Time Gravity…
Read the full statement (408 words)
3M™ Attest™ Super Rapid Steam Biological Indicator 1592:
Use the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3SM™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
Cycle Type | Exposure Temperature | Exposure Time
Gravity Displacement | 250°F (121°C) | 30 minutes
Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 15, 20, 30, or 35 minutes
Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 3,3.5,4,5.5, or 6 minutes
Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 3 or 4 minutes
Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3, 3.5, or 10 minutes
3M™ Attest™ Super Rapid Steam Challenge Pack 51582:
Use the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
Cycle Type | Exposure Temperature | Exposure Time
Gravity Displacement | 250°F (121°C) | 30 minutes
Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 30 minutes
Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 4 minutes
Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 4 minutes
Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3 minutes
3M™ Attest™ Auto-reader 490:
The 3M™ Attest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes.
3M™ Attest™ Auto-reader 490H:
The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60°C for a final fluorescent result at 24 minutes.
3M™ Attest™ Mini Auto-reader 490M:
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60°C for a final fluorescent result at 24 minutes.
The indications for use for Attest™ Biological Indicators are provided in the product’s Instructions for Use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213809: 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini 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/K213809
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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