510(k) · Cleared
Recalled · Class II · 2022Trophon
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 Feb 24, 2011 as substantially equivalent to K051305 (Cs Medical, LLC, 2005) and 1 other predicate after a 132-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it. It has been recalled once.
- Decided
- Feb 24, 2011
- Review
- 132 days
- Class
- Class II
- Product code
- OUJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K924334 (1994). 6 ancestors in all, the oldest K914145 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK924334 Cidex Formula 7* Long-Life Activated DialdehydeJohnson & Johnson Medical, Inc. · 1994
- 1 generation backK970230 SporoxReckitt Benckiser, Inc. · 1997
- This deviceK103059 TrophonNanosonics Limited · 2011
- Descendant · cites it directly · 2 of its ownK173865 trophon2Nanosonics Limited · 2018
- Descendant · 2 generations on · 0 of its ownK250434 trophon2Nanosonics · 2025
- Descendant · 2 generations on · 0 of its ownK241536 trophon Wireless Ultrasound Probe HolderNanosonics Limited · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924334 | Cidex Formula 7* Long-Life Activated Dialdehyde | Johnson & Johnson Medical, Inc. | 1994 | — |
| −1 | K970230 | Sporox | Reckitt Benckiser, Inc. | 1997 | — |
| 0 (this device) | K103059 | Trophon | Nanosonics Limited | 2011 | — |
| +1 | K173865 | trophon2 | Nanosonics Limited | 2018 | — |
| +2 | K250434 | trophon2 | Nanosonics | 2025 | — |
| +2 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K051305 | CS Medical TD-100 Transesophageal Probe Disinfector, Model TD-100, CS Medical TD-5…Summary page 1…: 21 CFR Sec. 892.1570 Diagnostic ultrasonic transducer (accessory to) Product Code: F ok Regulatory Class: II Predicate Devices: CS Medical TD-100 (K051305) Reckitt & Colman SporoX TM (K970230) Date Prepared: February 16, 2011 Description of the Dev… | 2005 |
| * | K970230 | SporoxSummary page 1…ssory to) Product Code: F ok Regulatory Class: II Predicate Devices: CS Medical TD-100 (K051305) Reckitt & Colman SporoX TM (K970230) Date Prepared: February 16, 2011 Description of the Device: The Nanosonics Trophon EPR is a software controlled devi… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173865 | trophon2 | 2018 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class II | Z-1602-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 13.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K173865 (Nanosonics Limited, 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K051305.
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. 2011, 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 EPIR 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…
Read the full statement (123 words)
The Trophon EPIR 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: 560C
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103059: Trophon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103059
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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