510(k) · Cleared
ClearedCelerity HP Incubator
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 May 14, 2019 as substantially equivalent to K171587 (STERIS Corporation, 2017) after a 92-day review. Its family tree reaches back 3 generations to 2002. 4 later devices descend from it.
- Decided
- May 14, 2019
- Review
- 92 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K004009 (2002). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK004009 3M Attest 290 Auto-Reader3M Company · 2002
- 2 generations backK123546 3M Attest (TM) Auto-Reader3M Company · 2013 · Recalled
- 1 generation backK171587 VERIFY Incubator for Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation · 2017
- This deviceK190297 Celerity HP IncubatorSTERIS Corporation · 2019
- Descendant · cites it directly · 3 of its ownK213881 Celerity IncubatorSTERIS Corporation · 2022
- Descendant · 2 generations on · 2 of its ownK223715 Celerity IncubatorSTERIS Corporation · 2023
- Descendant · 3 generations on · 0 of its ownK250061 Celerity IncubatorSTERIS Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK233681 ConFirm 20 Minute IncubatorSTERIS Corporation · 2023
Most influential descendants
Showing 4 of 4 · See all- K213881Celerity IncubatorSTERIS Corporation · 2022 · cites it directly3descendants
- K223715Celerity IncubatorSTERIS Corporation · 2023 · 2 generations on2descendants
- K250061Celerity IncubatorSTERIS Corporation · 2025 · 3 generations on0descendants
- K233681ConFirm 20 Minute IncubatorSTERIS Corporation · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K004009 | 3M Attest 290 Auto-Reader | 3M Company | 2002 | — |
| −2 | K123546 | 3M Attest (TM) Auto-Reader | 3M Company | 2013 | 1 |
| −1 | K171587 | VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation | 2017 | — |
| 0 (this device) | K190297 | Celerity HP Incubator | STERIS Corporation | 2019 | — |
| +1 | K213881 | Celerity Incubator | STERIS Corporation | 2022 | — |
| +2 | K223715 | Celerity Incubator | STERIS Corporation | 2023 | — |
| +3 | K250061 | Celerity Incubator | STERIS Corporation | 2025 | — |
| +3 | K233681 | ConFirm 20 Minute Incubator | STERIS Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K171587 | VERIFY Incubator for Assert VH2O2 Self-Contained Biological IndicatorSummary page 5…lass II Classification Name: Indicator, Biological Sterilization Process (21 CFR 880.2800, FRC) 2. Predicate Device K171587 - VERIFY® Incubator for Assert™ VH2O2 Self-Contained Biological Indicators (name changed to Celerity HP Incubator after clea… | 2017 |
| † | K173670 | CELERITY 20 Steam Incubator | 2018 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213881 | Celerity Incubator | 2022 | 3 |
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 17 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K213881 (STERIS Corporation, 2022) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K171587.
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?
Use the Celerity HP Incubator to incubate and automatically read Celerity 20 HP Biological Indicators at 57 °C for 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/K190297 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190297: Celerity HP Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190297
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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