510(k) Report

FDA applicant

Nanosonics Limited

Macquarie Park, AU7 decisions2011–20261 recall

FDA records 7 decisions for Nanosonics Limited (Macquarie Park, AU) from 2011 to 2026: 6 510(k) clearances and 1 De Novo grant. Most are in product codes OUJ (High Level Disinfection Reprocessing…) and SEW (Automated Endoscope Channel Cleaner). Its devices cite 7 predicates, 4 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Nanosonics”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Nanosonics Limited’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2011: 22018: 12024: 12025: 22026 (partial year): 1
2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2011high 1 (2022) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Nanosonics Limited by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nanosonics Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OUJHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist4decisions
  • SEWAutomated Endoscope Channel Cleaner2decisions
  • JOJIndicator, Physical/Chemical Sterilization Process1decision

Whose devices does it build on?

Its devices cite 7 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K173865trophon2Nanosonics Limited · 20182cite it
  • DEN240018CORIS SystemNanosonics Limited · 20251cites it
  • K103059TrophonNanosonics Limited · 20111cites it
  • K103126Trophon Chemical IndicatorNanosonics Limited · 20111cites it

What has FDA decided for it lately?

  • K253267CORIS SystemNanosonics Limited · 2026
  • K250434trophon2Nanosonics · 2025
  • DEN240018CORIS SystemNanosonics Limited · 2025
  • K241536trophon Wireless Ultrasound Probe HolderNanosonics Limited · 2024
  • K173865trophon2Nanosonics Limited · 2018
  • K103126Trophon Chemical IndicatorNanosonics Limited · 2011
  • K103059TrophonNanosonics Limited · 20111 recall

All 6 as Nanosonics Limited →The one decision as Nanosonics →

What has been recalled?

1 recall linked to its devices; the latest:

  • K103059NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For…May 25, 2022Class II