510(k) · Cleared
ClearedVERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles
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 Apr 28, 2017 as substantially equivalent to K121593 (3M Company, 2013) after a 109-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Apr 28, 2017
- Review
- 109 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K926364 (1995). 8 ancestors in all, the oldest K900771 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK926364 Attest Brand Rapid Readout Biological Ind. #129X3M Health Care, Ltd. · 1995
- 3 generations backK090569 Modification to: Attest Rapid Readout Biological Indicator, Mode 12923M Company · 2009
- 2 generations backK121484 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest…3M Company · 2012
- 1 generation backK121593 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest…3M Company · 2013
- This deviceK170070 VERIFY ASSERT STEAM Process Challenge Device for Gravity CyclesSTERIS Corporation · 2017
- Descendant · cites it directly · 0 of its ownK173629 CELERITY 20 Steam Process Challenge Device for Gravity CyclesSTERIS Corporation · 2018
Most influential descendants
Showing 1 of 1 · See all- K173629CELERITY 20 Steam Process Challenge Device for Gravity CyclesSTERIS Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K926364 | Attest Brand Rapid Readout Biological Ind. #129X | 3M Health Care, Ltd. | 1995 | — |
| −3 | K090569 | Modification to: Attest Rapid Readout Biological Indicator, Mode 1292 | 3M Company | 2009 | — |
| −2 | K121484 | 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM)… | 3M Company | 2012 | — |
| −1 | K121593 | 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super… | 3M Company | 2013 | — |
| 0 (this device) | K170070 | VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles | STERIS Corporation | 2017 | — |
| +1 | K173629 | CELERITY 20 Steam Process Challenge Device for Gravity Cycles | STERIS Corporation | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K121593 | 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super Rapid 5…Summary page 5…or, Biological Sterilization Process (21 CFR 880.2800, FRC) 2. Predicate Device 3M Attest Super Rapid 5 Steam-Plus Challenge Pack K121593 3. Description of Device The VERIFY™ Assert™ STEAM Process Challenge Device for Gravity Cycles (Gravity PCD), cont… | 2013 |
| † | K162701 | VERIFY Assert Self-Contained Biological Indicator | 2017 |
| † | K121484 | 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM) Auto-Reader | 2012 |
| † | K163587 | VERIFY Incubator for Assert Self Contained Biological Indicators | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173629 | CELERITY 20 Steam Process Challenge Device for Gravity Cycles | 2018 | 0 |
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 22 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K173629 (STERIS Corporation, 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K121593.
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™ STEAM Process Challenge Device for Gravity Cycles is used for qualification, routine microbial monitoring, and cycle monitoring of steam sterilizers.
The validated steam sterilization cycles include:
• 250°F (121°C) 30-minute gravity
• 270°F (132°C) 15-minute gravity
The VERIFY Assert Self-Contained Indicator within the Process challenge device must be used with the VERIFY Incubator for Assert Self Contained Biological Indicators. When used in conjunction with the VERIFY Incubator for Assert Self Contained Biological Indicators, the VERIFY Assert Self-Contained Indicator within the Process challenge device provides a fluorescent result within 40 minutes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170070: VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170070
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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