510(k) · Cleared
ClearedCelerity 20 Steam Biological Indicator for IUSS
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 Jan 8, 2021 as substantially equivalent to K103277 (3M Company-3M Health Care, 2011) after a 113-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Jan 8, 2021
- Review
- 113 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K900771 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK900771 Attest Brand Rapid Readout Biological Indicator3M Company · 1990
- 1 generation backK103277 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest…3M Company-3M Health Care · 2011 · Recalled
- This deviceK202721 Celerity 20 Steam Biological Indicator for IUSSSTERIS Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900771 | Attest Brand Rapid Readout Biological Indicator | 3M Company | 1990 | — |
| −1 | K103277 | 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490… | 3M Company-3M Health Care | 2011 | 1 |
| 0 (this device) | K202721 | Celerity 20 Steam Biological Indicator for IUSS | STERIS Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K103277 | 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-ReaderSummary page 5…ogical Sterilization Process (21 CFR 880.2800, FRC) 2. Predicate Device 3M Attest 1491 Super Rapid Readout Biological Indicator, K103277 3. Reference Device Celerity 20 Steam Biological Indicator, cleared under K173634 and modified under K181686 4.… | 2011 |
| † | K173634 | CELERITY 20 Steam Biological Indicator | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 3 companies; a new generation was cleared every 20.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 4 other devices also cite its predicate K103277.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 for IUSS is used for monitoring and qualification testing of the following
steam sterilization cycles:
Gravity 270°F (132°C) 3 minutes
Gravity 270°F (132°C) 10 minutes
Gravity 275°F (135°C) 3 minutes
Gravity 275°F (135°C) 10 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/K202721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202721: Celerity 20 Steam Biological Indicator for IUSS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202721
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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