510(k) · Cleared
ClearedCelerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Sep 5, 2019 as substantially equivalent to K183295 (Steris Corporations, 2019) after a 38-day review. Its family tree reaches back 6 generations to 2002. 4 later devices descend from it.
- Decided
- Sep 5, 2019
- Review
- 38 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K994055 (2002). 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
- 5 generations backK072510 Verify V-Pro Chemical Indicator, Versions 1 and 2STERIS Corporation · 2007
- 4 generations backK091174 Verify V-Pro Chemical Indicator, Version 1A: Verify V-Pro Chemical…STERIS Corporation · 2009
- 3 generations backK140515 Verify Hpu Chemical Indicator/ Verify Vaporized VH202 Process…STERIS Corporation · 2014
- 2 generations backK172746 VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process…STERIS Corporation · 2018
- 1 generation backK183295 Celerity HP Chemical Indicator (CI)Steris Corporations · 2019
- This deviceK192020 Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process…STERIS Corporation · 2019
- 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
- Descendant · cites it directly · 0 of its ownK233187 Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)Steris · 2023
Most influential descendants
Showing 4 of 4 · 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
- K233187Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)Steris · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K994055 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2002 | 1 |
| −5 | K072510 | Verify V-Pro Chemical Indicator, Versions 1 and 2 | STERIS Corporation | 2007 | — |
| −4 | K091174 | Verify V-Pro Chemical Indicator, Version 1A: Verify V-Pro Chemical Indicator… | STERIS Corporation | 2009 | — |
| −3 | K140515 | Verify Hpu Chemical Indicator/ Verify Vaporized VH202 Process Indicator… | STERIS Corporation | 2014 | — |
| −2 | K172746 | VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator… | STERIS Corporation | 2018 | — |
| −1 | K183295 | Celerity HP Chemical Indicator (CI) | Steris Corporations | 2019 | — |
| 0 (this device) | K192020 | Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator… | STERIS Corporation | 2019 | — |
| +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 | — |
| +1 | K233187 | Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) | Steris | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 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 JOJ? 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 JOJ device
- #1 K261992 3M™ Attest™ Steam Chemical Integrator (1243A…score 13.3 · 5 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 |
|---|---|---|---|
| * | K183295 | Celerity HP Chemical Indicator (CI)Summary page 7…assification Name: Physical/chemical sterilization process indicator 510(k) Submitter/Holder: STERIS Corporation 510(k) Number: K183295 1.2 Reference Device Trade Name: VERIFY® V-PRO Chemical Indicator Common/Usual Name:… | 2019 |
| † | K172746 | VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive… | 2018 |
What descends from it? (4)
2 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 17 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K231488 (Steris, 2023) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JOJ devicesJOJ Indicator, Physical/Chemical 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 · JOJ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOJ
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOJ
12in 2025
MAUDE reports naming product code JOJ, 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 | 8 | 140 | 0 | 1 |
| 2008 | 9 | 57 | 2 | 1 |
| 2009 | 7 | 188 | 2 | 9 |
| 2010 | 6 | 115 | 0 | 3 |
| 2011 | 13 | 151 | 2 | 1 |
| 2012 | 7 | 224 | 0 | 8 |
| 2013 | 6 | 212 | 0 | 6 |
| 2014 | 6 | 198 | 0 | 11 |
| 2015 | 8 | 188 | 0 | 7 |
| 2016 | 4 | 150 | 0 | 11 |
| 2017 | 7 | 172 | 0 | 35 |
| 2018 | 5 | 150 | 0 | 12 |
| 2019 | 12 | 38 | 0 | 8 |
| 2020 | 7 | 108 | 0 | 6 |
| 2021 | 4 | 87 | 1 | 29 |
| 2022 | 8 | 90 | 0 | 23 |
| 2023 | 4 | 53 | 1 | 39 |
| 2024 | 12 | 71 | 0 | 25 |
| 2025 | 6 | 90 | 0 | 12 |
| 2026 | 3 | 30 | 0 | — |
What is it indicated for?
The Celerity™ HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the: • Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or • Standard…
Read the full statement (277 words)
The Celerity™ HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the:
• Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.
The Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the:
• Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology.
The VERIFY V24 Self-Contained Biological Indicator Vial Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the:
• Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192020: Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192020
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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