510(k) · Cleared
ClearedRaven Protest - Steam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Raven Biological Laboratories, Inc. · FRC Indicator, Biological Sterilization Process
Cleared on Aug 9, 2004 as substantially equivalent to K963841 (Sgm Biotech, Inc., 1997) after a 76-day review. Its family tree reaches back 2 generations to 1980. 2 later devices descend from it.
- Decided
- Aug 9, 2004
- Review
- 76 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K801109 (1980). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK801109 Proof (Biological/Chemical Indicator)Amsco Co. · 1980
- 1 generation backK963841 EztestSgm Biotech, Inc. · 1997 · Recalled
- This deviceK041386 Raven Protest - SteamRaven Biological Laboratories, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK082756 Raven Protest - Steam Biological IndicatorRaven Biological Laboratories, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK112018 Smart Read Eztest SteamMesa Laboratories, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801109 | Proof (Biological/Chemical Indicator) | Amsco Co. | 1980 | — |
| −1 | K963841 | Eztest | Sgm Biotech, Inc. | 1997 | 1 |
| 0 (this device) | K041386 | Raven Protest - Steam | Raven Biological Laboratories, Inc. | 2004 | — |
| +1 | K082756 | Raven Protest - Steam Biological Indicator | Raven Biological Laboratories, Inc. | 2009 | — |
| +1 | K112018 | Smart Read Eztest Steam | Mesa Laboratories, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K963841 | EztestSummary page 1…Indicator for Steam Classification: Class II Predicate Device: SGM EZTest® - Steam (K963841) DESCRIPTION The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothe… | 1997 |
What descends from it? (2)
2 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 24 years and passes through 3 companies; a new generation was cleared every 16.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K082756 (Raven Biological Laboratories, Inc., 2009) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K963841.
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 | — |
What is it indicated for?
Raven ProTest - Steam is a self-contained Biological Indicator inoculated with viable Geobacillus stearothermophilus spores and is intended for monitoring the efficacy of steam sterilization cycles (121°C gravity displacement and 121°C - 135°C prevacuum cycles). Raven ProTest - Steam has a validated reduced incubation time of 24 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041386 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041386: Raven Protest - Steam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041386
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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