510(k) Report

FDA product code · General hospital

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

OUJClass II21 CFR 892.1570510(k) required4 decisions since 20110 recalls

4 FDA decisions since 2011. 510(k) reviews decided 2021–2025 took a median of 146 days (half between 133 and 159). No recall names this code. The most-cited predicate is K173865, named by 2 later devices.

To provide high level disinfection of ultrasound transducers. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general hospital panel

Twenty years of OUJ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OUJ

1in 2025

2011: 12018: 12024: 12025: 1
2007high 1 (2011) · low 0 (2007)2026

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

2014: 12017: 12018: 12021: 12023: 12025: 1
2007high 1 (2014) · low 0 (2007)2025

MAUDE reports naming product code OUJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20111—00
20120—00
20130—00
20140—01
20150—00
20160—00
20170—01
20181—01
20190—00
20200—00
20210—01
20220—00
20230—01
20241—00
20251—01
20260—0—
FIG. 1 — OUJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OUJ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do OUJ devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K173865trophon2Nanosonics Limited · 20182cite it
  • K103059TrophonNanosonics Limited · 20111cites it

Which OUJ devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K250434trophon2Nanosonics · 20254generations
  • K241536trophon Wireless Ultrasound Probe HolderNanosonics Limited · 20244generations
  • K173865trophon2Nanosonics Limited · 20183generations
  • K103059TrophonNanosonics Limited · 20112generations

What has FDA decided in OUJ lately?

  • K250434trophon2Nanosonics · 2025
  • K241536trophon Wireless Ultrasound Probe HolderNanosonics Limited · 2024
  • K173865trophon2Nanosonics Limited · 2018
  • K103059TrophonNanosonics Limited · 20111 recall

All 4 OUJ decisions →

Related product codes

Other codes under 21 CFR 892.1570.

PSW High Level Disinfection Reprocessing…OQQ Diagnostic Ultrasonic Transducer, RoboticMUI Media, Coupling, UltrasoundITX Transducer, Ultrasonic, Diagnostic