510(k) · Cleared
ClearedSterilucent VH2O2 Chemical Indicators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilucent, Inc. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Oct 21, 2019 as substantially equivalent to K140566 (Crosstex International, 2014) and 1 other predicate after an 87-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Oct 21, 2019
- Review
- 87 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K921910 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK921910 Sterrad Chemical IndicatorJohnson & Johnson Medical, Inc. · 1993
- 4 generations backK030680 Spsmedical Gas Plasma Chemical IndicatorSpsmedical Supply Corp. · 2003
- 3 generations backK090650 Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSpsmedical Supply Corp. · 2009
- 2 generations backK110152 Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSpsmedical Supply Corp. · 2011
- 1 generation backK140566 Spsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator TapeCrosstex International · 2014
- This deviceK191999 Sterilucent VH2O2 Chemical IndicatorsSterilucent, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921910 | Sterrad Chemical Indicator | Johnson & Johnson Medical, Inc. | 1993 | — |
| −4 | K030680 | Spsmedical Gas Plasma Chemical Indicator | Spsmedical Supply Corp. | 2003 | — |
| −3 | K090650 | Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators | Spsmedical Supply Corp. | 2009 | — |
| −2 | K110152 | Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators | Spsmedical Supply Corp. | 2011 | — |
| −1 | K140566 | Spsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator Tape | Crosstex International | 2014 | — |
| 0 (this device) | K191999 | Sterilucent VH2O2 Chemical Indicators | Sterilucent, Inc. | 2019 | — |
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 |
|---|---|---|---|
| * | K140566 | Spsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator TapeSummary page 4…ation: 21 CFR 880.2800(b) Class: II Product Code: JOJ Predicate Device(s): SPSmedical VH2O2 Indicators (K140566/ K110152) Device Description: The Sterilucent VH2O2 Chemical Indicator is a Class 1/Type 1 process… | 2014 |
| * | K110152 | Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSummary page 4…21 CFR 880.2800(b) Class: II Product Code: JOJ Predicate Device(s): SPSmedical VH2O2 Indicators (K140566/ K110152) Device Description: The Sterilucent VH2O2 Chemical Indicator is a Class 1/Type 1 process… | 2011 |
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 26 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K140566.
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. 2019, 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 Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer (Lumen & Flexible), STERRAD® 100S (Standard & Long), 200, 100NX (Standard, Flex & Express), NX (Standard & Advanced), STERIS® VPRO™ 1, V-PRO™ 1 Plus (Lumen & Non-Lumen), VPRO® 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191999 · printed Nov 4, 2026
Cite this page
510(k) Report. “K191999: Sterilucent VH2O2 Chemical Indicators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K191999
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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