510(k) · Cleared
Cleared3MTM AttestTM Rapid 5 Steam-Plus Test Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Complany · FRC Indicator, Biological Sterilization Process
Cleared on Jun 1, 2020 as substantially equivalent to K193154 (3M Company, 2020) after a 90-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Jun 1, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K926364 (1995). 10 ancestors in all, the oldest K900771 (1990). No later device cites it as a predicate yet.
- 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 backK193154 3M Attest Super Rapid 5 Steam-Plus Challenge Pack3M Company · 2020 · Recalled
- This deviceK200536 3MTM AttestTM Rapid 5 Steam-Plus Test Pack3M Complany · 2020
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 | K193154 | 3M Attest Super Rapid 5 Steam-Plus Challenge Pack | 3M Company | 2020 | 2 |
| 0 (this device) | K200536 | 3MTM AttestTM Rapid 5 Steam-Plus Test Pack | 3M Complany | 2020 | — |
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 |
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 |
|---|---|---|---|
| * | K193154 | 3M Attest Super Rapid 5 Steam-Plus Challenge PackSummary page 5…Sterilization Process [21 CFR § 880.2800(a), FRC] Predicate Device: 3M™ Attest™ Super Rapid 5 Steam-Plus Test Pack 41482V, K193154 Indications for Use: 3M™ Attest™ Rapid 5 Steam-Plus Test Pack 41382: Use the 3M™ Attest™ Rapid 5 Steam-Plus Test Pack 41382… | 2020 |
| † | K771080 | Steam Sterilization Indicator | 1977 |
| † | K090569 | Modification to: Attest Rapid Readout Biological Indicator, Mode 1292 | 2009 |
| † | K173437 | 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M… | 2018 |
| † | K191236 | 3M™ Attest™ Steam Chemical Integrators | 2019 |
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?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 10 ancestors have a recall of any class.
- 2 other devices also cite its predicate K193154.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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™ Rapid 5 Steam-Plus Test Pack 41382:
Use the 3M™ Attest™ Rapid 5 Steam-Plus Test Pack 41382 to qualify or monitor:
• 121°C (250°F) 30-minute gravity steam sterilization cycles;
• 132°C (270°F) 4-minute dynamic-air-removal steam sterilization cycles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200536 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200536: 3MTM AttestTM Rapid 5 Steam-Plus Test Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200536
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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