510(k) · Cleared
Clearedtrophon2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanosonics · OUJ High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
Cleared on Aug 5, 2025 as substantially equivalent to K173865 (Nanosonics Limited, 2018) after a 172-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Aug 5, 2025
- Review
- 172 days
- Class
- Class II
- Product code
- OUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K924334 (1994). 8 ancestors in all, the oldest K914145 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK924334 Cidex Formula 7* Long-Life Activated DialdehydeJohnson & Johnson Medical, Inc. · 1994
- 3 generations backK970230 SporoxReckitt Benckiser, Inc. · 1997
- 2 generations backK103059 TrophonNanosonics Limited · 2011 · Recalled
- 1 generation backK173865 trophon2Nanosonics Limited · 2018
- This deviceK250434 trophon2Nanosonics · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924334 | Cidex Formula 7* Long-Life Activated Dialdehyde | Johnson & Johnson Medical, Inc. | 1994 | — |
| −3 | K970230 | Sporox | Reckitt Benckiser, Inc. | 1997 | — |
| −2 | K103059 | Trophon | Nanosonics Limited | 2011 | 1 |
| −1 | K173865 | trophon2 | Nanosonics Limited | 2018 | — |
| 0 (this device) | K250434 | trophon2 | Nanosonics | 2025 | — |
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 |
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 K241536 trophon Wireless Ultrasound Probe Holderscore 9.0 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K173865 | trophon2Summary page 5…1570 Product Code: OUJ V. PREDICATE DEVICE Predicate Device Trade Name: trophon2 510(k) Number: K173865 Company Name: Nanosonics Ltd. VI. DEVICE DESCRIPTION The trophon2 is a software-controlled device… | 2018 |
| † | K103126 | Trophon Chemical Indicator | 2011 |
| † | K241536 | trophon Wireless Ultrasound Probe Holder | 2024 |
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 31 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K173865.
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. 2025, 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 transducers. High-Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber contain 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 transducers. High-Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber contain 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: 4 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/K250434 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250434: trophon2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250434
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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