510(k) · Cleared
Clearedtrophon Wireless Ultrasound Probe Holder
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 Sep 27, 2024 as substantially equivalent to K173865 (Nanosonics Limited, 2018) after a 120-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Sep 27, 2024
- Review
- 120 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 deviceK241536 trophon Wireless Ultrasound Probe HolderNanosonics Limited · 2024
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) | 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 |
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
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.
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 30 years and passes through 3 companies; a new generation was cleared every 7.2 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. 2024, 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 trophon Wireless Ultrasound Probe Holder is an accessory to be added to the trophon EPR and trophon2 to allow wireless ultrasound probes to be disinfected. trophon EPR: The trophon EPR is designed to provide High-Level Disinfection of ultrasound transducers. The system uses the trophon Disinfectant which is intended to be used exclusively with the trophon EPR device. The trophon Disinfectant is intended for use as a High-Level Disinfectant to be used…
Read the full statement (256 words)
The trophon Wireless Ultrasound Probe Holder is an accessory to be added to the trophon EPR and trophon2 to allow wireless ultrasound probes to be disinfected.
trophon EPR:
The trophon EPR is designed to provide High-Level Disinfection of ultrasound transducers. The system uses the trophon Disinfectant which is intended to be used exclusively with the trophon EPR device.
The trophon Disinfectant is intended for use as a High-Level Disinfectant to be used exclusively with the trophon EPR for the High-Level Disinfection of ultrasound transducers.
The trophon EPR is suitable for use in general hospital and health care facilities by trained personnel.
The trophon EPR system consists of a multiple use instrument combined with a single use disinfectant, delivered from a multi-dose cartridge.
The trophon Disinfectant 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
trophon2:
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: 7 minutes
Minimum Concentration: 31.5%
Minimum Disinfectant Dose: 1.0 g
Minimum Chamber Temperature: 56°C
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/K241536 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241536: trophon Wireless Ultrasound Probe Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241536
Report an extraction error
Are you the manufacturer?
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