# Nanosonics Limited

- Location (FDA's records): Macquarie Park, AU
- FDA decisions: 7 (2011–2026): 6 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Nanosonics Limited (6); Nanosonics (1)
- Product codes: OUJ (4), SEW (2), JOJ (1)
- Predicates its devices cite: 7 (4 its own); citations of its devices by later devices: 5 (4 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cs Medical, LLC: 1 (https://510kreport.com/company/cs-medical)
- Reckitt Benckiser, LLC: 1 (https://510kreport.com/company/reckitt-benckiser)
- Serim Research Corp.: 1 (https://510kreport.com/company/serim-research)

## Firms that cite its devices most
- True Indicating, LLC: 1 (https://510kreport.com/company/true-indicating)

## Its most-cited devices
- K173865: trophon2 (2018), cited by 2
- DEN240018: CORIS System (2025), cited by 1
- K103059: Trophon (2011), cited by 1
- K103126: Trophon Chemical Indicator (2011), cited by 1

## Recent decisions
- K253267: CORIS System (Mar 5, 2026)
- K250434: trophon2 (Aug 5, 2025)
- DEN240018: CORIS System (Mar 19, 2025)
- K241536: trophon Wireless Ultrasound Probe Holder (Sep 27, 2024)
- K173865: trophon2 (Apr 24, 2018)
- K103126: Trophon Chemical Indicator (Mar 3, 2011)
- K103059: Trophon (Feb 24, 2011)

Source page: https://510kreport.com/company/nanosonics