Nanosonics Limited: FDA clearances and approvals
Nanosonics Limited has 5 FDA 510(k) clearances (first 2011, latest 2026), plus 1 De Novo decision, across 3 product codes in 1 review panel. Median 510(k) review time: 132 days. Since 2017 its median was 125 days, against 94 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 125 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 120 |
| 2025 | 0 | — |
| 2026 | 1 | 157 |
Review time against the same product codes
Since 2017, Nanosonics Limited's cleared 510(k)s took a median 125 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OUJ | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist | 3 | 3 |
| SEW | Automated Endoscope Channel Cleaner | 2 | 1 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Nanosonics Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253267 | CORIS System | SEW | 2026-03-05 | 157 |
| K241536 | trophon Wireless Ultrasound Probe Holder | OUJ | 2024-09-27 | 120 |
| K173865 | trophon2 | OUJ | 2018-04-24 | 125 |
| K103126 | TROPHON CHEMICAL INDICATOR | JOJ | 2011-03-03 | 132 |
| K103059 | TROPHON | OUJ | 2011-02-24 | 132 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240018 | De Novo | Automated Endoscope Channel Cleaner | 2025-03-19 |
Recalls
openFDA lists no recalls under a recalling firm named Nanosonics Limited.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Nanosonics Limited have?
Nanosonics Limited has 5 FDA 510(k) clearances (first 2011, latest 2026), plus 1 De Novo decision, across 3 product codes in 1 review panel.
How long does FDA take to clear Nanosonics Limited's 510(k)s?
The median time from FDA receipt to decision across Nanosonics Limited's cleared 510(k)s is 132 days. Since 2017: 125 days, versus 94 days for all cleared 510(k)s in the same product codes.
What devices does Nanosonics Limited make?
Its most frequent FDA product codes are OUJ (High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist, 3); SEW (Automated Endoscope Channel Cleaner, 2); JOJ (Indicator, Physical/Chemical Sterilization Process, 1).
Has Nanosonics Limited had device recalls?
openFDA lists no recalls under a recalling firm name matching Nanosonics Limited. Related entities may recall under other names.
Next steps
- See all 5 Nanosonics Limited clearances with predicates and recalls
- Run predicate analysis for product code OUJ, Nanosonics Limited's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.