510(k) · Cleared
ClearedCELERITY HP Chemical Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator
Cleared on Jan 7, 2022 as substantially equivalent to K203284 (3M Company, 2020) after a 99-day review. Its family tree reaches back 7 generations to 1993. 3 later devices descend from it.
- Decided
- Jan 7, 2022
- Review
- 99 days
- Class
- Class II
- Product code
- QKM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K921910 (1993). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
- 6 generations backK013228 3M Comply 1248 Gas Plasma Chemical IndicatorMinnesota Mining and Mfg. Co. · 2002 · Recalled
- 5 generations backK150622 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2015
- 4 generations backK170321 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2017
- 3 generations backK183211 3M Comply Hydrogen Peroxide Chemical Indicator3M Company · 2019
- 2 generations backK193110 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator…3M Healthcare · 2020 · Recalled
- 1 generation backK203284 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator3M Company · 2020
- This deviceK213262 CELERITY HP Chemical IndicatorSTERIS Corporation · 2022
- Descendant · cites it directly · 2 of its ownK231488 Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical…Steris · 2023
- Descendant · 2 generations on · 1 of its ownK240760 CELERITY HP Indicator TapeSteris · 2024
- Descendant · 3 generations on · 0 of its ownK242189 CELERITY HP Indicator Tape (PCC077)Steris · 2024
Most influential descendants
Showing 3 of 3 · See all- K231488Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY…Steris · 2023 · cites it directly2descendants
- K240760CELERITY HP Indicator TapeSteris · 2024 · 2 generations on1descendant
- K242189CELERITY HP Indicator Tape (PCC077)Steris · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921910 | Sterrad Chemical Indicator | Johnson & Johnson Medical, Inc. | 1993 | — |
| −6 | K013228 | 3M Comply 1248 Gas Plasma Chemical Indicator | Minnesota Mining and Mfg. Co. | 2002 | 1 |
| −5 | K150622 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2015 | — |
| −4 | K170321 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2017 | — |
| −3 | K183211 | 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company | 2019 | — |
| −2 | K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Healthcare | 2020 | 1 |
| −1 | K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator | 3M Company | 2020 | — |
| 0 (this device) | K213262 | CELERITY HP Chemical Indicator | STERIS Corporation | 2022 | — |
| +1 | K231488 | Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical… | Steris | 2023 | — |
| +2 | K240760 | CELERITY HP Indicator Tape | Steris | 2024 | — |
| +3 | K242189 | CELERITY HP Indicator Tape (PCC077) | Steris | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 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 QKM? 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 QKM device
- #1 K212022 3M Attest Vaporized Hydrogen Peroxide…score 8.0 · 7 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 |
|---|---|---|---|
| * | K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical IndicatorSummary page 5…Classification Name: Physical/chemical sterilization processindicator 510(k) Submitter/Holder: 3M Corporation 510(k) Number: K203284 2. Device Description The Celerity™ HP Chemical Indicator is a chemical indicator strip consisting of… | 2020 |
| † | K192020 | Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive… | 2019 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231488 | Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY… | 2023 | 2 |
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 29 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K231488 (Steris, 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K203284.
How does its category compare?
All QKM devicesQKM A Chemical Vapor Sterilization Multivariable Chemical Indicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QKM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QKM
Too few QKM 510(k)s in any year since 2007 to give a median.
Recalls per year · QKM
No recall names QKM since 2007.
Adverse event reports per year · QKM
No MAUDE report names QKM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Celerity™ HP Chemical Indicator is a vaporized hydrogen peroxide multivariable chemical indicator. It is designed for routine monitoring of the following cycles:
* Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
» Standard, Advanced, Express, Flex or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.
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/K213262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213262: CELERITY HP Chemical Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213262
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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