510(k) · Cleared
ClearedCELERITY 20 Steam 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 Feb 12, 2018 as substantially equivalent to K121484 (3M Company, 2012) after an 80-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Feb 12, 2018
- Review
- 80 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K926364 (1995). 6 ancestors in all, the oldest K900771 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK926364 Attest Brand Rapid Readout Biological Ind. #129X3M Health Care, Ltd. · 1995
- 2 generations backK090569 Modification to: Attest Rapid Readout Biological Indicator, Mode 12923M Company · 2009
- 1 generation backK121484 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest…3M Company · 2012
- This deviceK173634 CELERITY 20 Steam Biological IndicatorSTERIS Corporation · 2018
- Descendant · cites it directly · 0 of its ownK200126 VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation · 2020
- Descendant · cites it directly · 0 of its ownK181686 CELERITY 20 Steam Biological IndicatorSTERIS Corporation · 2018
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 |
|---|---|---|---|---|---|
| −3 | K926364 | Attest Brand Rapid Readout Biological Ind. #129X | 3M Health Care, Ltd. | 1995 | — |
| −2 | K090569 | Modification to: Attest Rapid Readout Biological Indicator, Mode 1292 | 3M Company | 2009 | — |
| −1 | K121484 | 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM)… | 3M Company | 2012 | — |
| 0 (this device) | K173634 | CELERITY 20 Steam Biological Indicator | STERIS Corporation | 2018 | — |
| +1 | K200126 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | 2020 | — |
| +1 | K181686 | CELERITY 20 Steam Biological Indicator | STERIS Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K121484 | 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM) Auto-ReaderSummary page 5…Biological Sterilization Process (21 CFR 880.2800, FRC) 2. Predicate Device 3M Attest Super Rapid Readout Biological Indicator, K121484 3. Description of Device The product is intended to monitor the critical parameters of steam sterilization cycles… | 2012 |
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 23 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K200126 (STERIS Corporation, 2020) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K121484.
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 Biological Indicator is used for routine monitoring,
qualification testing, load monitoring and product testing of the following steam sterilization
cycles:
Dynamic Air Removal 270°F (132°C) 4 minutes
Dynamic Air Removal 275°F (135°C) 3 minutes
Gravity 250°F (121°C) 30 minutes
Gravity 270°F (132°C) 15 minutes.
When used in conjunction with the Celerity™ Steam Incubator, the Incubator provides a
fluorescent result within 20 minutes.
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/K173634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173634: CELERITY 20 Steam 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/K173634
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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