510(k) · Cleared
ClearedVerify V-Pro Chemical Indicator, Version 1A: Verify V-Pro Chemical Indicator; Version 2A: Adhesive 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 Oct 27, 2009 as substantially equivalent to K072510 (STERIS Corporation, 2007) after a 188-day review. Its family tree reaches back 2 generations to 2002. 9 later devices descend from it.
- Decided
- Oct 27, 2009
- Review
- 188 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K994055 (2002). 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
- 1 generation backK072510 Verify V-Pro Chemical Indicator, Versions 1 and 2STERIS Corporation · 2007
- This deviceK091174 Verify V-Pro Chemical Indicator, Version 1A: Verify V-Pro Chemical…STERIS Corporation · 2009
- Descendant · cites it directly · 7 of its ownK140515 Verify Hpu Chemical Indicator/ Verify Vaporized VH202 Process…STERIS Corporation · 2014
- Descendant · 2 generations on · 6 of its ownK172746 VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process…STERIS Corporation · 2018
- Descendant · 3 generations on · 5 of its ownK183295 Celerity HP Chemical Indicator (CI)Steris Corporations · 2019
- Descendant · 4 generations on · 4 of its ownK192020 Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process…STERIS Corporation · 2019
- Descendant · 3 generations on · 2 of its ownK231488 Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical…Steris · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K140515Verify Hpu Chemical Indicator/ Verify Vaporized VH202 Process Indicator Adhesive LabelSTERIS Corporation · 2014 · cites it directly7descendants
- K172746VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive…STERIS Corporation · 2018 · 2 generations on6descendants
- K183295Celerity HP Chemical Indicator (CI)Steris Corporations · 2019 · 3 generations on5descendants
- K192020Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive…STERIS Corporation · 2019 · 4 generations on4descendants
- K231488Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY…Steris · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K994055 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2002 | 1 |
| −1 | K072510 | Verify V-Pro Chemical Indicator, Versions 1 and 2 | STERIS Corporation | 2007 | — |
| 0 (this device) | K091174 | Verify V-Pro Chemical Indicator, Version 1A: Verify V-Pro Chemical Indicator… | STERIS Corporation | 2009 | — |
| +1 | 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 | — |
| +3 | K183295 | Celerity HP Chemical Indicator (CI) | Steris Corporations | 2019 | — |
| +4 | K192020 | Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator… | STERIS Corporation | 2019 | — |
| +3 | K231488 | Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical… | Steris | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K072510 | Verify V-Pro Chemical Indicator, Versions 1 and 2Summary page 2…on process indicator (21 CFR 880.2800 (b), Product Code JOJ). 2. Predicate Device Verify® V-PRO Chemical Indicator - Version 1 and 2 (K0725 10) 3. Device Description The Verify® V-PRO Chemical Indicator is provided as two formats: , Version 1A: Verify® V… | 2007 |
What descends from it? (9)
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 7 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K140515 (STERIS Corporation, 2014) has gone furthest, with 7 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. 2009, 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 Verify® V-PRO Chemical Indicator (Version 1A) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2A) are Class 1 vaporized hydrogen peroxide sterilization process indicators that conform to ANSI/AAMI/ISO 11140-1: 2005. They are designed to distinguish between processed and unprocessed units when placed within (Version 1A) or affixed to (Version 2A) sterilization wraps, trays or pouches to indicate, through a visible change from magenta…
Read the full statement (295 words)
The Verify® V-PRO Chemical Indicator (Version 1A) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2A) are Class 1 vaporized hydrogen peroxide sterilization process indicators that conform to ANSI/AAMI/ISO 11140-1: 2005. They are designed to distinguish between processed and unprocessed units when placed within (Version 1A) or affixed to (Version 2A) sterilization wraps, trays or pouches to indicate, through a visible change from magenta to yellow, when the device (Version 1A) or pack (Version 2A) has been exposed to a V-PRO 1 Low Temperature sterilization process (Lumen Cycle) or V-PRO 1 Plus Low Temperature sterilization process (Lumen or Non-Lumen cycle). This product is designed for use exclusively in the Amsco V-PRO 1 Low Temperature Sterilization System and Amsco V-PRO 1 Plus Low Temperature Sterilization System at 50 °C using Vaprox TM HC Sterilant.
The Verify® V-PRO Chemical Indicator (Version 1A) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2A) intended for use in vaporized hydrogen peroxide sterilization processes. The Verify® V-PRO Chemical Indicator (Version IA) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2A) change color from magenta to yellow when exposed to the appropriate cycle conditions of temperature, sterilant concentration and duration, as shown in the table below:
Model | Temperature | Sterilant Concentration | Cycle Type | Exposure Time
Verify Version 1A | 50 °C | 2.1 g H 2 02 x 4 injections | Lumen | 32 minutes
Verify Version 2A | 50 °C | 2.1 g H 2 0 2 x 4 injections | Lumen | 32 minutes
Verify Version 1A | 50 °C | 2.1 g H2 0 2 x 4 injections | Non-Lumen | 12 minutes
Verify Version 2A | 50 °C | 2.1 g H 20 2 x 4 injections | Non-Lumen | 12 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091174 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091174: Verify V-Pro Chemical Indicator, Version 1A: Verify V-Pro Chemical Indicator; Version 2A: Adhesive Label.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091174
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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