510(k) · Cleared
Recalled · Class III · 2022Celerity 20 Steam Process Challenge Device for Dynamic Air Removal 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 Feb 21, 2018 as substantially equivalent to K121593 (3M Company, 2013) after an 89-day review. Its family tree reaches back 4 generations to 1995. It has been recalled once.
- Decided
- Feb 21, 2018
- Review
- 89 days
- Class
- Class II
- Product code
- FRC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K926364 (1995). 8 ancestors in all, the oldest K900771 (1990). No later device cites it as a predicate yet.
- 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 deviceK173626 Celerity 20 Steam Process Challenge Device for Dynamic Air Removal…STERIS Corporation · 2018
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) | K173626 | Celerity 20 Steam Process Challenge Device for Dynamic Air Removal 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 |
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…Sterilization Process Indicator (21 CFR 880.2800, FRC) 2. Predicate Device 3M Attest Super Rapid 5 Steam-Plus Challenge Pack K121593 Reference Device: Verify Assert Steam Process Challenge Device, K162945 3. Description of Device The Celerity 20… | 2013 |
| † | K162945 | VERIFY ASSERT STEAM Process Challenge Device | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 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. 2018, 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 Celerity™ 20 Steam Challenge Pack is used for qualification, routine microbial monitoring, and load monitoring of steam sterilizers.
The validated steam sterilization cycles include:
• 270°F (132°C) 4-minute dynamic air removal (Prevac, SFPP)
• 275°F (135°C) 3-minute dynamic air removal (Prevac, SFPP)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173626: Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173626
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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