510(k) · Cleared
ClearedSpsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator Tape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crosstex International · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Nov 24, 2014 as substantially equivalent to K110152 (Spsmedical Supply Corp., 2011) after a 264-day review. Its family tree reaches back 4 generations to 1993. 3 later devices descend from it.
- Decided
- Nov 24, 2014
- Review
- 264 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921910 (1993). 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
- 3 generations backK030680 Spsmedical Gas Plasma Chemical IndicatorSpsmedical Supply Corp. · 2003
- 2 generations backK090650 Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSpsmedical Supply Corp. · 2009
- 1 generation backK110152 Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSpsmedical Supply Corp. · 2011
- This deviceK140566 Spsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator TapeCrosstex International · 2014
- Descendant · cites it directly · 0 of its ownK200096 Crosstex VH2O2 Chemical IndicatorsCrosstex International, Inc. (A Cantel Medical Company) · 2021
- Descendant · cites it directly · 0 of its ownK191999 Sterilucent VH2O2 Chemical IndicatorsSterilucent, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK143520 SPSmedical VH202 External Indicator (Container Cards), SPSmedical…Crosstex · 2015
Most influential descendants
Showing 3 of 3 · See all- K200096Crosstex VH2O2 Chemical IndicatorsCrosstex International, Inc. (A Cantel Medical Company) · 2021 · cites it directly0descendants
- K191999Sterilucent VH2O2 Chemical IndicatorsSterilucent, Inc. · 2019 · cites it directly0descendants
- K143520SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External…Crosstex · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921910 | Sterrad Chemical Indicator | Johnson & Johnson Medical, Inc. | 1993 | — |
| −3 | K030680 | Spsmedical Gas Plasma Chemical Indicator | Spsmedical Supply Corp. | 2003 | — |
| −2 | K090650 | Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators | Spsmedical Supply Corp. | 2009 | — |
| −1 | K110152 | Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators | Spsmedical Supply Corp. | 2011 | — |
| 0 (this device) | K140566 | Spsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator Tape | Crosstex International | 2014 | — |
| +1 | K200096 | Crosstex VH2O2 Chemical Indicators | Crosstex International, Inc. (A Cantel Medical Company) | 2021 | — |
| +1 | K191999 | Sterilucent VH2O2 Chemical Indicators | Sterilucent, Inc. | 2019 | — |
| +1 | K143520 | SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202… | Crosstex | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 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 |
|---|---|---|---|
| * | K110152 | Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSummary page 4…ospital Product Code: JOJ Device Class: II PREDICATE DEVICE: The SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators cleared under K110152. DEVICE DESCRIPTION: The SPSmedical VH2O2 Indicators are single use process indicators which are cleared for use in verifying… | 2011 |
What descends from it? (3)
3 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 21 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K200096 (Crosstex International, Inc. (A Cantel Medical Company), 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K110152.
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. 2014, 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?
A chemical indicator for monitoring all cycles within the STERRAD ® 100S (Standard & Long), 200, 100NX (Standard, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO™ 1, V-PRO™ 1 Plus (Lumen & Non-lumen), V-PRO® maX (Flexible, Lumen & Non-lumen) and Sterilucent™ PSD-85 (Lumen & Non-lumen). The VH2O2 Indicators are intended to be used by health care providers with sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140566: Spsmedical VH2O2 Indicator Strips, Indicator Labels, 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/K140566
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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