510(k) · Cleared
Recalled · Class III · 2022VERIFY 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 K140499 (STERIS Corporation, 2014) after a 91-day review. Its family tree reaches back 6 generations to 2005. 9 later devices descend from it. It has been recalled once.
- Decided
- Aug 22, 2017
- Review
- 91 days
- Class
- Class II
- Product code
- FRC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K042450 (2005). 10 ancestors in all, the oldest K994055 (2002). 9 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK042450 Sterrad NX Challenge PackAdvanced Sterilization Products · 2005
- 5 generations backK051643 Sterrad Sterilizer Cyclesure Test PackAdvanced Sterilization Products · 2005
- 4 generations backK073618 Verify Sirius Biological Indicator Challenge PackSTERIS Corporation · 2009
- 3 generations backK092906 Verify Biological Indicator Challenge Pack for Vaporized VH202…STERIS Corporation · 2009
- 2 generations backK103331 Verify Biological Indicator Challenge Pack for Vaporized VH202…STERIS Corporation · 2011
- 1 generation backK140499 Verify V24 Self-Contained Biological Indicator for Vaporized VH202…STERIS Corporation · 2014
- This deviceK171504 VERIFY Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation · 2017
- Descendant · cites it directly · 8 of its ownK172752 CELERITY 20 HP Biological IndicatorSTERIS Corporation · 2018
- Descendant · 2 generations on · 6 of its ownK183294 CELERITY 20 HP Biological Indicator, CELERITY HP Challenge PackSTERIS Corporation · 2019
- Descendant · 3 generations on · 3 of its ownK223717 Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge PackSTERIS Corporation · 2023
- Descendant · 3 generations on · 1 of its ownK250044 Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge…STERIS Corporation · 2025
- Descendant · 3 generations on · 1 of its ownK231490 Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained…STERIS Corporation · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K172752CELERITY 20 HP Biological IndicatorSTERIS Corporation · 2018 · cites it directly8descendants
- K183294CELERITY 20 HP Biological Indicator, CELERITY HP Challenge PackSTERIS Corporation · 2019 · 2 generations on6descendants
- K223717Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge PackSTERIS Corporation · 2023 · 3 generations on3descendants
- K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…STERIS Corporation · 2025 · 3 generations on1descendant
- K231490Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological IndicatorSTERIS Corporation · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K042450 | Sterrad NX Challenge Pack | Advanced Sterilization Products | 2005 | — |
| −5 | K051643 | Sterrad Sterilizer Cyclesure Test Pack | Advanced Sterilization Products | 2005 | — |
| −4 | K073618 | Verify Sirius Biological Indicator Challenge Pack | STERIS Corporation | 2009 | — |
| −3 | K092906 | Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization | STERIS Corporation | 2009 | — |
| −2 | K103331 | Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization… | STERIS Corporation | 2011 | — |
| −1 | K140499 | Verify V24 Self-Contained Biological Indicator for Vaporized VH202… | STERIS Corporation | 2014 | — |
| 0 (this device) | K171504 | VERIFY Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation | 2017 | — |
| +1 | K172752 | CELERITY 20 HP Biological Indicator | STERIS Corporation | 2018 | — |
| +2 | K183294 | CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack | STERIS Corporation | 2019 | — |
| +3 | K223717 | Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack | STERIS Corporation | 2023 | — |
| +3 | K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack… | STERIS Corporation | 2025 | — |
| +3 | K231490 | Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological… | STERIS Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K140499 | Verify V24 Self-Contained Biological Indicator for Vaporized VH202 Sterilization ProcessesSummary page 5…, Biological Sterilization Process (21 CFR 880.2800, FRC) 2. Predicate Device VERIFY® V24 Self-Contained Biological Indicator, K140499 Reference Devices 3M Attest™ Rapid Readout Biological Indicator 1295, K160546 3. Description of Device The… | 2014 |
| † | K160546 | 3M Attest Rapid Readout Biological Indicator | 2016 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172752 | CELERITY 20 HP Biological Indicator | 2018 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class III | Z-1793-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K172752 (STERIS Corporation, 2018) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K140499.
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?
The VERIFY Assert VH2O2 Self-Contained Biological Indicator is used for routine monitoring, and qualification of Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX, and 60 Low Temperature Sterilizers in healthcare facilities.
When used in conjunction with the VERIFY Incubator for Assert VH2O2 SCBI, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 20 minutes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171504: VERIFY 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/K171504
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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