510(k) · Cleared
ClearedCelerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steris · FRC Indicator, Biological Sterilization Process
Cleared on Jun 6, 2025 as substantially equivalent to K250044 (STERIS Corporation, 2025) after a 28-day review. Its family tree reaches back 11 generations to 2005.
- Decided
- Jun 6, 2025
- Review
- 28 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K042450 (2005). 16 ancestors in all, the oldest K994055 (2002). No later device cites it as a predicate yet.
- Root · 11 generations backK042450 Sterrad NX Challenge PackAdvanced Sterilization Products · 2005
- 7 generations between
- 3 generations backK183294 CELERITY 20 HP Biological Indicator, CELERITY HP Challenge PackSTERIS Corporation · 2019
- 2 generations backK223717 Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge PackSTERIS Corporation · 2023
- 1 generation backK250044 Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge…STERIS Corporation · 2025
- This deviceK251452 Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge…Steris · 2025
Show all 11 generations
- Root · 11 generations backK042450 Sterrad NX Challenge PackAdvanced Sterilization Products · 2005
- 10 generations backK051643 Sterrad Sterilizer Cyclesure Test PackAdvanced Sterilization Products · 2005
- 9 generations backK073618 Verify Sirius Biological Indicator Challenge PackSTERIS Corporation · 2009
- 8 generations backK092906 Verify Biological Indicator Challenge Pack for Vaporized VH202…STERIS Corporation · 2009
- 7 generations backK103331 Verify Biological Indicator Challenge Pack for Vaporized VH202…STERIS Corporation · 2011
- 6 generations backK140499 Verify V24 Self-Contained Biological Indicator for Vaporized VH202…STERIS Corporation · 2014
- 5 generations backK171504 VERIFY Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation · 2017 · Recalled
- 4 generations backK172752 CELERITY 20 HP Biological IndicatorSTERIS Corporation · 2018
- 3 generations backK183294 CELERITY 20 HP Biological Indicator, CELERITY HP Challenge PackSTERIS Corporation · 2019
- 2 generations backK223717 Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge PackSTERIS Corporation · 2023
- 1 generation backK250044 Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge…STERIS Corporation · 2025
- This deviceK251452 Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge…Steris · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K042450 | Sterrad NX Challenge Pack | Advanced Sterilization Products | 2005 | — |
| −10 | K051643 | Sterrad Sterilizer Cyclesure Test Pack | Advanced Sterilization Products | 2005 | — |
| −9 | K073618 | Verify Sirius Biological Indicator Challenge Pack | STERIS Corporation | 2009 | — |
| −8 | K092906 | Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization | STERIS Corporation | 2009 | — |
| −7 | K103331 | Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization… | STERIS Corporation | 2011 | — |
| −6 | K140499 | Verify V24 Self-Contained Biological Indicator for Vaporized VH202… | STERIS Corporation | 2014 | — |
| −5 | K171504 | VERIFY Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation | 2017 | 1 |
| −4 | K172752 | CELERITY 20 HP Biological Indicator | STERIS Corporation | 2018 | — |
| −3 | K183294 | CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack | STERIS Corporation | 2019 | — |
| −2 | K223717 | Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack | STERIS Corporation | 2023 | — |
| −1 | K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack… | STERIS Corporation | 2025 | — |
| 0 (this device) | K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack… | Steris | 2025 | — |
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 |
| 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 |
|---|---|---|---|
| * | K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…Summary page 7…dicator Classification Name: Indicator, Biological Sterilization Process 510(k) Submitter/Holder STERIS Corporation 510(k) Number: K250044 Proprietary Name Celerity 5 HP Challenge Pack (LCB059) Common/usual Name Biological indicator Cha… | 2025 |
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 20 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 16 ancestors have a recall of any class.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 5 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles: • Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems • Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear® • Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without…
Read the full statement (334 words)
The Celerity 5 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:
• Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
• Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear®
• Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear®.
When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 5 minutes.
The Celerity HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.
The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The challenge pack is not intended for routine monitoring of the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers.
The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:
• Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
• Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear®
• Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear®.
When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 20 minutes.
The Celerity HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.
The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The challenge pack is not intended for routine monitoring of the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251452 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251452: Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251452
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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