510(k) · Cleared
ClearedAttest Brand Rapid Readout Biological Indicator
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 Jul 3, 1990 after a 133-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 36 later devices descend from it.
- Decided
- Jul 3, 1990
- Review
- 133 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 0
36 later devices descend from it, 1 citing it directly.
- This deviceK900771 Attest Brand Rapid Readout Biological Indicator3M Company · 1990
- Descendant · cites it directly · 35 of its ownK103277 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest…3M Company-3M Health Care · 2011 · Recalled
- Descendant · 2 generations on · 31 of its ownK121484 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest…3M Company · 2012
- Descendant · 2 generations on · 12 of its ownK140392 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company · 2014
- Descendant · 3 generations on · 11 of its ownK152060 3M Attest Rapid Readout Biological Indicator 12953M Company · 2015
- Descendant · 3 generations on · 11 of its ownK121593 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest…3M Company · 2013
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K1032773M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-Reader3M Company-3M Health Care · 2011 · cites it directly35descendants
- K1214843M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM) Auto-Reader3M Company · 2012 · 2 generations on31descendants
- K1403923M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company · 2014 · 2 generations on12descendants
- K1520603M Attest Rapid Readout Biological Indicator 12953M Company · 2015 · 3 generations on11descendants
- K1215933M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super Rapid 5…3M Company · 2013 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900771 | Attest Brand Rapid Readout Biological Indicator | 3M Company | 1990 | — |
| +1 | K103277 | 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490… | 3M Company-3M Health Care | 2011 | 1 |
| +2 | K121484 | 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM)… | 3M Company | 2012 | — |
| +2 | K140392 | 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader | 3M Company | 2014 | — |
| +3 | K152060 | 3M Attest Rapid Readout Biological Indicator 1295 | 3M Company | 2015 | — |
| +3 | K121593 | 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super… | 3M Company | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 9 | 0 |
| 2020 | 8 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (36)
See all 361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103277 | 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-Reader | 2011 | 35 |
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, K103277 (3M Company-3M Health Care, 2011) has gone furthest, with 35 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 | — |
https://510kreport.com/device/K900771 · printed Nov 5, 2026
Cite this page
510(k) Report. “K900771: Attest Brand Rapid Readout Biological Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K900771
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026