510(k) · Cleared
ClearedVERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · FRC Indicator, Biological Sterilization Process
Cleared on Aug 22, 2017 as substantially equivalent to K123546 (3M Company, 2013) after an 83-day review. Its family tree reaches back 2 generations to 2002. 6 later devices descend from it.
- Decided
- Aug 22, 2017
- Review
- 83 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K004009 (2002). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK004009 3M Attest 290 Auto-Reader3M Company · 2002
- 1 generation backK123546 3M Attest (TM) Auto-Reader3M Company · 2013 · Recalled
- This deviceK171587 VERIFY Incubator for Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation · 2017
- Descendant · cites it directly · 4 of its ownK190297 Celerity HP IncubatorSTERIS Corporation · 2019
- Descendant · 2 generations on · 3 of its ownK213881 Celerity IncubatorSTERIS Corporation · 2022
- Descendant · 3 generations on · 2 of its ownK223715 Celerity IncubatorSTERIS Corporation · 2023
- Descendant · 4 generations on · 0 of its ownK250061 Celerity IncubatorSTERIS Corporation · 2025
- Descendant · 4 generations on · 0 of its ownK233681 ConFirm 20 Minute IncubatorSTERIS Corporation · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K190297Celerity HP IncubatorSTERIS Corporation · 2019 · cites it directly4descendants
- K213881Celerity IncubatorSTERIS Corporation · 2022 · 2 generations on3descendants
- K223715Celerity IncubatorSTERIS Corporation · 2023 · 3 generations on2descendants
- K250061Celerity IncubatorSTERIS Corporation · 2025 · 4 generations on0descendants
- K233681ConFirm 20 Minute IncubatorSTERIS Corporation · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K004009 | 3M Attest 290 Auto-Reader | 3M Company | 2002 | — |
| −1 | K123546 | 3M Attest (TM) Auto-Reader | 3M Company | 2013 | 1 |
| 0 (this device) | K171587 | VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation | 2017 | — |
| +1 | K190297 | Celerity HP Incubator | STERIS Corporation | 2019 | — |
| +2 | K213881 | Celerity Incubator | STERIS Corporation | 2022 | — |
| +3 | K223715 | Celerity Incubator | STERIS Corporation | 2023 | — |
| +4 | K250061 | Celerity Incubator | STERIS Corporation | 2025 | — |
| +4 | K233681 | ConFirm 20 Minute Incubator | STERIS Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K123546 | 3M Attest (TM) Auto-ReaderSummary page 5…n Name: Indicator, Biological Sterilization Process (21 CFR 880.2800, FRC) 2. Predicate Device 3M Attest 390 Auto-reader, K123546 Reference Device: VERIFY® Incubator for Assert™ Self Contained Biological Indicators, K163587 3.… | 2013 |
| † | K163587 | VERIFY Incubator for Assert Self Contained Biological Indicators | 2017 |
What descends from it? (6)
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 15 years and passes through 2 companies; a new generation was cleared every 11.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K190297 (STERIS Corporation, 2019) 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. 2017, 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 VERIFY Incubator for Assert VH2O2 Self Contained Biological Indicators (Incubator) to incubate and automatically read VERIFY Assert VH2O2 Self-Contained Biological Indicators at 57 °C for a fluorescent result within 20 minutes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171587: VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171587
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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