510(k) · Cleared
ClearedCelerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)
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 Oct 27, 2023 as substantially equivalent to K192020 (STERIS Corporation, 2019) after a 29-day review. Its family tree reaches back 7 generations to 2002.
- Decided
- Oct 27, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K994055 (2002). No later device cites it as a predicate yet.
- Root · 7 generations backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
- 6 generations backK072510 Verify V-Pro Chemical Indicator, Versions 1 and 2STERIS Corporation · 2007
- 5 generations backK091174 Verify V-Pro Chemical Indicator, Version 1A: Verify V-Pro Chemical…STERIS Corporation · 2009
- 4 generations backK140515 Verify Hpu Chemical Indicator/ Verify Vaporized VH202 Process…STERIS Corporation · 2014
- 3 generations backK172746 VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process…STERIS Corporation · 2018
- 2 generations backK183295 Celerity HP Chemical Indicator (CI)Steris Corporations · 2019
- 1 generation backK192020 Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process…STERIS Corporation · 2019
- This deviceK233187 Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)Steris · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K994055 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2002 | 1 |
| −6 | K072510 | Verify V-Pro Chemical Indicator, Versions 1 and 2 | STERIS Corporation | 2007 | — |
| −5 | K091174 | Verify V-Pro Chemical Indicator, Version 1A: Verify V-Pro Chemical Indicator… | STERIS Corporation | 2009 | — |
| −4 | K140515 | Verify Hpu Chemical Indicator/ Verify Vaporized VH202 Process Indicator… | STERIS Corporation | 2014 | — |
| −3 | K172746 | VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator… | STERIS Corporation | 2018 | — |
| −2 | K183295 | Celerity HP Chemical Indicator (CI) | Steris Corporations | 2019 | — |
| −1 | K192020 | Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator… | STERIS Corporation | 2019 | — |
| 0 (this device) | K233187 | Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) | Steris | 2023 | — |
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 |
|---|---|---|---|
| * | K192020 | Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive…Summary page 6…fication Number: 21 CFR 880.2800 Product Code: JOJ 2. Predicate Device K192020 Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label Table 1. Device Comparison Table for Modified Label and Predic… | 2019 |
| † | K231490 | Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 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 ™ 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, Fast or Specialty 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 as stated in the FDA summary.
https://510kreport.com/device/K233187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233187: Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233187
Report an extraction error
Are you the manufacturer?
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