510(k) · Cleared
Clearedtrophon2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanosonics Limited · OUJ High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
Cleared on Apr 24, 2018 as substantially equivalent to K103059 (Nanosonics Limited, 2011) after a 125-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Apr 24, 2018
- Review
- 125 days
- Class
- Class II
- Product code
- OUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K924334 (1994). 7 ancestors in all, the oldest K914145 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK924334 Cidex Formula 7* Long-Life Activated DialdehydeJohnson & Johnson Medical, Inc. · 1994
- 2 generations backK970230 SporoxReckitt Benckiser, Inc. · 1997
- 1 generation backK103059 TrophonNanosonics Limited · 2011 · Recalled
- This deviceK173865 trophon2Nanosonics Limited · 2018
- Descendant · cites it directly · 0 of its ownK250434 trophon2Nanosonics · 2025
- Descendant · cites it directly · 0 of its ownK241536 trophon Wireless Ultrasound Probe HolderNanosonics Limited · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924334 | Cidex Formula 7* Long-Life Activated Dialdehyde | Johnson & Johnson Medical, Inc. | 1994 | — |
| −2 | K970230 | Sporox | Reckitt Benckiser, Inc. | 1997 | — |
| −1 | K103059 | Trophon | Nanosonics Limited | 2011 | 1 |
| 0 (this device) | K173865 | trophon2 | Nanosonics Limited | 2018 | — |
| +1 | K250434 | trophon2 | Nanosonics | 2025 | — |
| +1 | K241536 | trophon Wireless Ultrasound Probe Holder | Nanosonics Limited | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 OUJ? 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 OUJ device
- #1 K250434 trophon2score 10.7 · 4 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K103059 | TrophonSummary page 4…nfection Reprocessing Instrument for Ultrasonic Transducers, Mist Product Code: OUJ Regulatory Class: II Predicate Devices: Trophon EPR (K103059) Nanosonics Limited Date Prepared: April 23, 2018 Page 1 of… | 2011 |
What descends from it? (2)
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 24 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K250434 (Nanosonics, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OUJ devicesOUJ High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OUJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OUJ
Too few OUJ 510(k)s in any year since 2007 to give a median.
Recalls per year · OUJ
No recall names OUJ since 2007.
Adverse event reports per year · OUJ
1in 2025
MAUDE reports naming product code OUJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The trophon2 is designed to provide High-Level Disinfection (HLD) of validated ultrasound probes. High-Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber containing the ultrasound probe. The trophon2 system consists of a multiple use instrument combined with a single use disinfectant “trophon Sonex-HL”, delivered from a multi-dose cartridge. The trophon2 is suitable for…
Read the full statement (104 words)
The trophon2 is designed to provide High-Level Disinfection (HLD) of validated ultrasound probes. High-Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber containing the ultrasound probe.
The trophon2 system consists of a multiple use instrument combined with a single use disinfectant “trophon Sonex-HL”, delivered from a multi-dose cartridge.
The trophon2 is suitable for use in general hospital and health care facilities by trained personnel.
The trophon Sonex-HL should be used with the following contact conditions:
Minimum Operational Cycle Time: 7 minutes
Minimum Concentration: 31.5%
Minimum Disinfectant Dose: 1.0 g
Minimum Chamber Temperature: 56°C
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173865: trophon2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173865
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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