510(k) · Cleared
ClearedSteam Sterilization Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Info-Chem · FRC Indicator, Biological Sterilization Process
Cleared on Jul 14, 1977 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jul 14, 1977
- Review
- 29 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK771080 Steam Sterilization IndicatorInfo-Chem · 1977
- Descendant · cites it directly · 4 of its ownK101249 Sterigage Model 1243RA, 1243RB, 1243RE3M Company · 2010
- Descendant · 2 generations on · 3 of its ownK191236 3M™ Attest™ Steam Chemical Integrators3M Company · 2019
- Descendant · 3 generations on · 2 of its ownK193254 3M Attest Steam Chemical Integrator3M Company · 2019
- Descendant · 4 generations on · 1 of its ownK220942 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)3M Company · 2022 · Recalled
- Descendant · 5 generations on · 0 of its ownK261992 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLC · 2026
Most influential descendants
Showing 5 of 5 · See all- K101249Sterigage Model 1243RA, 1243RB, 1243RE3M Company · 2010 · cites it directly4descendants
- K1912363M™ Attest™ Steam Chemical Integrators3M Company · 2019 · 2 generations on3descendants
- K1932543M Attest Steam Chemical Integrator3M Company · 2019 · 3 generations on2descendants
- K2209423M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)3M Company · 2022 · 4 generations on1descendant
- K2619923M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLC · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K771080 | Steam Sterilization Indicator | Info-Chem | 1977 | — |
| +1 | K101249 | Sterigage Model 1243RA, 1243RB, 1243RE | 3M Company | 2010 | — |
| +2 | K191236 | 3M™ Attest™ Steam Chemical Integrators | 3M Company | 2019 | — |
| +3 | K193254 | 3M Attest Steam Chemical Integrator | 3M Company | 2019 | — |
| +4 | K220942 | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) | 3M Company | 2022 | 2 |
| +5 | K261992 | 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) | Solventum US, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101249 | Sterigage Model 1243RA, 1243RB, 1243RE | 2010 | 4 |
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, K101249 (3M Company, 2010) has gone furthest, with 4 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/K771080 · printed Nov 4, 2026
Cite this page
510(k) Report. “K771080: Steam Sterilization Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K771080
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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