510(k) · Cleared
ClearedCelerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steris · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Aug 7, 2023 as substantially equivalent to K192020 (STERIS Corporation, 2019) and 3 other predicates after a 76-day review. Its family tree reaches back 8 generations to 1993. 2 later devices descend from it.
- Decided
- Aug 7, 2023
- Review
- 76 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K921910 (1993). 16 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
- 7 generations backK013228 3M Comply 1248 Gas Plasma Chemical IndicatorMinnesota Mining and Mfg. Co. · 2002 · Recalled
- 6 generations backK150622 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2015
- 5 generations backK170321 3M Comply Hydrogen Peroxide Chemical Indicator 12483M Company · 2017
- 4 generations backK183211 3M Comply Hydrogen Peroxide Chemical Indicator3M Company · 2019
- 3 generations backK193110 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator…3M Healthcare · 2020 · Recalled
- 2 generations backK203284 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator3M Company · 2020
- 1 generation backK213262 CELERITY HP Chemical IndicatorSTERIS Corporation · 2022
- This deviceK231488 Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical…Steris · 2023
- Descendant · cites it directly · 1 of its ownK240760 CELERITY HP Indicator TapeSteris · 2024
- Descendant · 2 generations on · 0 of its ownK242189 CELERITY HP Indicator Tape (PCC077)Steris · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921910 | Sterrad Chemical Indicator | Johnson & Johnson Medical, Inc. | 1993 | — |
| −7 | K013228 | 3M Comply 1248 Gas Plasma Chemical Indicator | Minnesota Mining and Mfg. Co. | 2002 | 1 |
| −6 | K150622 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2015 | — |
| −5 | K170321 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | 2017 | — |
| −4 | K183211 | 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company | 2019 | — |
| −3 | K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Healthcare | 2020 | 1 |
| −2 | K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator | 3M Company | 2020 | — |
| −1 | K213262 | CELERITY HP Chemical Indicator | STERIS Corporation | 2022 | — |
| 0 (this device) | K231488 | Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical… | Steris | 2023 | — |
| +1 | K240760 | CELERITY HP Indicator Tape | Steris | 2024 | — |
| +2 | K242189 | CELERITY HP Indicator Tape (PCC077) | Steris | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K192020 | Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive…Summary page 5…Sterilization Process Indicator 510(k) Submitter/Holder: STERIS Corporation 510(k) Number: K192020 2. Device Description The CelerityTM HP Chemical Indicator is an ISO 11140-1:2014 Type 1 vaporized hyd… | 2019 |
| * | K213262 | CELERITY HP Chemical IndicatorSummary page 8…Physical/chemical Sterilization Process Indicator 510(k) Submitter/Holder: STERIS Corporation 510(k) Number: K213262 2. Device Description The Celerity™ HP Multivariable Chemical Indicator is a chemical indicator strip consisting of… | 2022 |
| * | K172746 | VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive…Summary page 12…terilization Process Indicator 510(k) Submitter/Holder: STERIS Corporation 510(k) Number: K172746 2. Device Description The VERIFY HPU Chemical Indicator (Chemical Indicator) is a Type 1 process ind… | 2018 |
| * | K183293 | VERIFY VH202 Indicator TapeSummary page 15…Physical/chemical Sterilization Process Indicator 510(k) Submitter/Holder: STERIS Corporation 510(k) Number: K183293 2. Device Description The VERIFY VH2O2 Indicator Tape (Indicator Tape) is a ¾” wide crepe paper tape printed with d… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240760 | CELERITY HP Indicator Tape | 2024 | 1 |
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 30 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 16 ancestors have a recall of any class.
- Of its descendants, K240760 (Steris, 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K192020.
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. 2023, 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 or lighter, when the device has been exposed to the: • Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization…
Read the full statement (357 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 or lighter, when the device has been exposed to the:
• Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty 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™ HP Multivariable 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, Fast or Specialty 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 VERIFY® HPU 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 to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen, Flexible, Fast Non Lumen, or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System.
The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.
The tape may be used in the following sterilization 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.
• 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 without ALLClear.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231488: Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231488
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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