510(k) · Cleared
Cleared3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super Rapid 5 Steam-Plus Challenge 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 Mar 15, 2013 as substantially equivalent to K925496 (Pymah Corp., 1994) and 1 other predicate after a 288-day review. Its family tree reaches back 3 generations to 1995. 11 later devices descend from it.
- Decided
- Mar 15, 2013
- Review
- 288 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K926364 (1995). 7 ancestors in all, the oldest K900771 (1990). 11 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK926364 Attest Brand Rapid Readout Biological Ind. #129X3M Health Care, Ltd. · 1995
- 2 generations backK090569 Modification to: Attest Rapid Readout Biological Indicator, Mode 12923M Company · 2009
- 1 generation backK121484 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest…3M Company · 2012
- This deviceK121593 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest…3M Company · 2013
- Descendant · cites it directly · 7 of its ownK173519 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super…3M Company · 2018 · Recalled
- Descendant · 2 generations on · 3 of its ownK193154 3M Attest Super Rapid 5 Steam-Plus Challenge Pack3M Company · 2020 · Recalled
- Descendant · 2 generations on · 2 of its ownK192550 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM…3M Company · 2020
- Descendant · 3 generations on · 1 of its ownK213809 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super…3M Company · 2022
- Descendant · cites it directly · 1 of its ownK170070 VERIFY ASSERT STEAM Process Challenge Device for Gravity CyclesSTERIS Corporation · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K1735193M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus…3M Company · 2018 · cites it directly7descendants
- K1931543M Attest Super Rapid 5 Steam-Plus Challenge Pack3M Company · 2020 · 2 generations on3descendants
- K1925503MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid…3M Company · 2020 · 2 generations on2descendants
- K2138093M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge…3M Company · 2022 · 3 generations on1descendant
- K170070VERIFY ASSERT STEAM Process Challenge Device for Gravity CyclesSTERIS Corporation · 2017 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K926364 | Attest Brand Rapid Readout Biological Ind. #129X | 3M Health Care, Ltd. | 1995 | — |
| −2 | K090569 | Modification to: Attest Rapid Readout Biological Indicator, Mode 1292 | 3M Company | 2009 | — |
| −1 | K121484 | 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM)… | 3M Company | 2012 | — |
| 0 (this device) | K121593 | 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super… | 3M Company | 2013 | — |
| +1 | K173519 | 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5… | 3M Company | 2018 | 1 |
| +2 | K193154 | 3M Attest Super Rapid 5 Steam-Plus Challenge Pack | 3M Company | 2020 | 2 |
| +2 | K192550 | 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super… | 3M Company | 2020 | — |
| +3 | K213809 | 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam… | 3M Company | 2022 | — |
| +1 | K170070 | VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles | STERIS Corporation | 2017 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 4 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K925496 | Ati Disposable Biological-Plus Test PackSummary page 1…r, Biological Sterilization Process . (21 CFR § 880.2800(a)) FRC Class Il 3M Attest™ Steam-Plus Pack, formerly ATI® Disposable Biological-Plus Test Pack cleared under K925496, acquired by 3M ) ~ 3M Attest™ 1492V Super Rapid Readout Biological Indicator for Steam and 3M Attest™ 490 Auto-reader (K121484)… | 1994 |
| * | K121484 | 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM) Auto-Reader Cleared while this submission was under review Summary page 1…Biological-Plus Test Pack cleared under K925496, acquired by 3M ) ~ 3M Attest™ 1492V Super Rapid Readout Biological Indicator for Steam and 3M Attest™ 490 Auto-reader (K121484) : 3% Description of Device: The 3M Attest™ [496V Super Rapid Readout Steam and 41482V Super Rapid 5 Steam-Plus… | 2012 |
What descends from it? (11)
See all 113 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?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K173519 (3M Company, 2018) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K925496.
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?
Use the 3M Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M Attest™ Super Rapid 5 Steam-Plus Steam Challenge Pack 41482V in conjunction with the 3M Attest™ Auto-reader 490 to qualify or monitor dynamic-air-removal (pre-vacuum) steam sterilization cycles of 270°F (132°C) at 4 minutes and 275°F (135°C) at 3 minutes.
The 3M Attest™ Super Rapid Readout Biological Indicator 1492V contained in the challenge pack provides a final fluorescent result in 1 hour. An optional visual pH color change result is observed in 48 hours.
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/K121593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121593: 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super Rapid 5 Steam-Plus Challenge Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121593
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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