510(k) · Cleared
ClearedSpsmedical Vaporized Hydrogen Peroxide Chemical Indicators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spsmedical Supply Corp. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Apr 15, 2011 as substantially equivalent to K030680 (Spsmedical Supply Corp., 2003) and 1 other predicate after an 86-day review. Its family tree reaches back 3 generations to 1993. 4 later devices descend from it.
- Decided
- Apr 15, 2011
- Review
- 86 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K921910 (1993). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
- 2 generations backK030680 Spsmedical Gas Plasma Chemical IndicatorSpsmedical Supply Corp. · 2003
- 1 generation backK090650 Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSpsmedical Supply Corp. · 2009
- This deviceK110152 Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSpsmedical Supply Corp. · 2011
- Descendant · cites it directly · 3 of its ownK140566 Spsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator TapeCrosstex International · 2014
- Descendant · 2 generations on · 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 · 2 generations on · 0 of its ownK143520 SPSmedical VH202 External Indicator (Container Cards), SPSmedical…Crosstex · 2015
Most influential descendants
Showing 4 of 4 · See all- K140566Spsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator TapeCrosstex International · 2014 · cites it directly3descendants
- K200096Crosstex VH2O2 Chemical IndicatorsCrosstex International, Inc. (A Cantel Medical Company) · 2021 · 2 generations on0descendants
- K191999Sterilucent VH2O2 Chemical IndicatorsSterilucent, Inc. · 2019 · cites it directly0descendants
- K143520SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External…Crosstex · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921910 | Sterrad Chemical Indicator | Johnson & Johnson Medical, Inc. | 1993 | — |
| −2 | K030680 | Spsmedical Gas Plasma Chemical Indicator | Spsmedical Supply Corp. | 2003 | — |
| −1 | K090650 | Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators | Spsmedical Supply Corp. | 2009 | — |
| 0 (this device) | K110152 | Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators | Spsmedical Supply Corp. | 2011 | — |
| +1 | K140566 | Spsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator Tape | Crosstex International | 2014 | — |
| +2 | K200096 | Crosstex VH2O2 Chemical Indicators | Crosstex International, Inc. (A Cantel Medical Company) | 2021 | — |
| +1 | K191999 | Sterilucent VH2O2 Chemical Indicators | Sterilucent, Inc. | 2019 | — |
| +2 | K143520 | SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202… | Crosstex | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K030680 | Spsmedical Gas Plasma Chemical IndicatorSummary page 1…80JOJ Predicate Device: SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators (K030680 and K090650) Device Description: SPSmedical Vaporized Hydrogen Peroxide (H0) Chemical Indicators… | 2003 |
| * | K090650 | Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSummary page 1…80JOJ Predicate Device: SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators (K030680 and K090650) Device Description: SPSmedical Vaporized Hydrogen Peroxide (H0) Chemical Indicators are process… | 2009 |
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 18 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K140566 (Crosstex International, 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K030680.
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. 2011, 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 SPSmedical H2 0 2 Chemical Indicators are indicated for use as process indicators for all vaporized hydrogen peroxide cycles in the STERRAD® IlOOS, 200, 100ONX, NX and STEMIS® V-ProlI, V-Pro 1 Plus and V-Pro maX sterilizers. They are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed items. Indicators change to a signal color of Blue after exposure to vapor hydrogen peroxide.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110152: Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110152
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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