510(k) · Cleared
ClearedCELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack
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 3, 2019 as substantially equivalent to K172752 (STERIS Corporation, 2018) and 1 other predicate after a 37-day review. Its family tree reaches back 8 generations to 2005. 6 later devices descend from it.
- Decided
- Jan 3, 2019
- Review
- 37 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K042450 (2005). 13 ancestors in all, the oldest K994055 (2002). 6 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK042450 Sterrad NX Challenge PackAdvanced Sterilization Products · 2005
- 7 generations backK051643 Sterrad Sterilizer Cyclesure Test PackAdvanced Sterilization Products · 2005
- 6 generations backK073618 Verify Sirius Biological Indicator Challenge PackSTERIS Corporation · 2009
- 5 generations backK092906 Verify Biological Indicator Challenge Pack for Vaporized VH202…STERIS Corporation · 2009
- 4 generations backK103331 Verify Biological Indicator Challenge Pack for Vaporized VH202…STERIS Corporation · 2011
- 3 generations backK140499 Verify V24 Self-Contained Biological Indicator for Vaporized VH202…STERIS Corporation · 2014
- 2 generations backK171504 VERIFY Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation · 2017 · Recalled
- 1 generation backK172752 CELERITY 20 HP Biological IndicatorSTERIS Corporation · 2018
- This deviceK183294 CELERITY 20 HP Biological Indicator, CELERITY HP Challenge PackSTERIS Corporation · 2019
- Descendant · cites it directly · 3 of its ownK223717 Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge PackSTERIS Corporation · 2023
- Descendant · cites it directly · 1 of its ownK250044 Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge…STERIS Corporation · 2025
- Descendant · cites it directly · 1 of its ownK231490 Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained…STERIS Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK260766 Celerity 5 HP Biological Indicator (LCB052)STERIS Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK252680 Celerity™ 20 HP Biological IndicatorSTERIS Corporation · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K223717Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge PackSTERIS Corporation · 2023 · cites it directly3descendants
- K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…STERIS Corporation · 2025 · cites it directly1descendant
- K231490Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological IndicatorSTERIS Corporation · 2023 · cites it directly1descendant
- K260766Celerity 5 HP Biological Indicator (LCB052)STERIS Corporation · 2026 · 2 generations on0descendants
- K252680Celerity™ 20 HP Biological IndicatorSTERIS Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K042450 | Sterrad NX Challenge Pack | Advanced Sterilization Products | 2005 | — |
| −7 | K051643 | Sterrad Sterilizer Cyclesure Test Pack | Advanced Sterilization Products | 2005 | — |
| −6 | K073618 | Verify Sirius Biological Indicator Challenge Pack | STERIS Corporation | 2009 | — |
| −5 | K092906 | Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization | STERIS Corporation | 2009 | — |
| −4 | K103331 | Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization… | STERIS Corporation | 2011 | — |
| −3 | K140499 | Verify V24 Self-Contained Biological Indicator for Vaporized VH202… | STERIS Corporation | 2014 | — |
| −2 | K171504 | VERIFY Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation | 2017 | 1 |
| −1 | K172752 | CELERITY 20 HP Biological Indicator | STERIS Corporation | 2018 | — |
| 0 (this device) | K183294 | CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack | STERIS Corporation | 2019 | — |
| +1 | 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 | — |
| +1 | K231490 | Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological… | STERIS Corporation | 2023 | — |
| +2 | K260766 | Celerity 5 HP Biological Indicator (LCB052) | STERIS Corporation | 2026 | — |
| +2 | K252680 | Celerity™ 20 HP Biological Indicator | STERIS Corporation | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K172752 | CELERITY 20 HP Biological IndicatorSummary page 6…l Sterilization Process [21 CFR 880.2800(a), FRC] 2. Predicate Device Biological Indicator CELERITY 20 HP Biological Indicator, K172752 (modified under K181429) 3. Description of Device – Biological Indicator The product is intended to monitor the vapor p… | 2018 |
| * | K173488 | CELERITY 20 HP Challenge PackSummary page 8…erilization Process Indicator (21 CFR 880.2800, FRC) 8. Predicate Device – Challenge Pack CELERITY 20 HP Challenge Pack K173488 (NOTE: The proposed and predicate devices are identical) January 2, 2109… | 2018 |
| † | K172474 | Celerity 20 HP Biological Indicator | 2017 |
| † | K140515 | Verify Hpu Chemical Indicator/ Verify Vaporized VH202 Process Indicator Adhesive Label | 2014 |
What descends from it? (6)
3 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 14 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K223717 (STERIS Corporation, 2023) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K172752.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 HP Biological Indicator is intended for routine monitoring of the following sterilizer cycles: * Lumen, Non Lumen, Fast Non Lumen, Fast and Flexible Cycles of the V-PRO: 1, 1 Plus, maX, maX2 and s2 Low Temperature Sterilization Systems. * STERRAD® 100S Sterilizer (Default Cycle) * Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear * Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX…
Read the full statement (175 words)
The Celerity 20 HP Biological Indicator is intended for routine monitoring of the following sterilizer cycles:
* Lumen, Non Lumen, Fast Non Lumen, Fast and Flexible Cycles of the V-PRO: 1, 1 Plus, maX, maX2 and s2 Low Temperature Sterilization Systems.
* STERRAD® 100S Sterilizer (Default Cycle)
* Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear
* Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear
When used in conjunction with the Celerity HP Incubator, the Celerity 20 HP BI provides a fluorescent result within 20 minutes
The CELERITY 20 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K183294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183294: CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183294
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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