510(k) · Cleared
ClearedTrophon Chemical Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanosonics Limited · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Mar 3, 2011 as substantially equivalent to K092346 (Serim Research Corp., 2010) after a 132-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Mar 3, 2011
- Review
- 132 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915170 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK915170 Pymah Cold Sterilog Glutaraldehyde MonitorPymah Corp. · 1992
- 1 generation backK092346 Serim D-Cide Gta 1.5% Test Strip, Model Part Number 5171Serim Research Corp. · 2010
- This deviceK103126 Trophon Chemical IndicatorNanosonics Limited · 2011
- Descendant · cites it directly · 0 of its ownK233413 Ultraphon Chemical Indicator (TRO-T and TRO-B)True Indicating, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K233413Ultraphon Chemical Indicator (TRO-T and TRO-B)True Indicating, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915170 | Pymah Cold Sterilog Glutaraldehyde Monitor | Pymah Corp. | 1992 | — |
| −1 | K092346 | Serim D-Cide Gta 1.5% Test Strip, Model Part Number 5171 | Serim Research Corp. | 2010 | — |
| 0 (this device) | K103126 | Trophon Chemical Indicator | Nanosonics Limited | 2011 | — |
| +1 | K233413 | Ultraphon Chemical Indicator (TRO-T and TRO-B) | True Indicating, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K092346 | Serim D-Cide Gta 1.5% Test Strip, Model Part Number 5171Summary page 1…nce: The Trophon Chemical Indicator is substantially equivalent to Serim 0-CIDE GTA 1.5% Test Strip. (K092346) Device Description: The device is a qualitative, single use, disc (26 mm in diameter)… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233413 | Ultraphon Chemical Indicator (TRO-T and TRO-B) | 2024 | 0 |
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 19 years and passes through 3 companies; a new generation was cleared every 17.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K233413 (True Indicating, LLC, 2024) has gone furthest, with 0 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. 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 Trophon Chemical Indicator is used exclusively for monitoring the High Level Disinfection process when placed within the Trophon EPR chamber.
The color of the Trophon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient in Trophon EPR-C40 disinfectant. This occurs above the minimum effective concentration (MEC) established for this solution.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103126: Trophon Chemical Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103126
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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