Enraf-Nonius, B.V.: FDA clearances and approvals
Enraf-Nonius, B.V. has 5 FDA 510(k) clearances (first 2003, latest 2025), across 5 product codes in 2 review panels. Median 510(k) review time: 156 days. Since 2017 its median was 244 days, against 145 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 | 1 | 120 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 244 |
| 2024 | 0 | — |
| 2025 | 2 | 212 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Enraf-Nonius, B.V.'s cleared 510(k)s took a median 244 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 145 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXY | Electrode, Cutaneous | 1 | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| ITH | Equipment, Traction, Powered | 1 | 1 |
Review panels
- Physical Medicine (4)
- Neurology (1)
Most recent Enraf-Nonius, B.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251083 | Compact II | IPF | 2025-09-12 | 156 |
| K243112 | Curapuls 670 | IMJ | 2025-06-25 | 268 |
| K230472 | Sonopuls 190 | IMI | 2023-10-24 | 244 |
| K151640 | ELTRAC 471 | ITH | 2015-10-16 | 120 |
| K030297 | FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 | GXY | 2003-04-28 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Enraf-Nonius, B.V..
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 Enraf-Nonius, B.V. have?
Enraf-Nonius, B.V. has 5 FDA 510(k) clearances (first 2003, latest 2025), across 5 product codes in 2 review panels.
How long does FDA take to clear Enraf-Nonius, B.V.'s 510(k)s?
The median time from FDA receipt to decision across Enraf-Nonius, B.V.'s cleared 510(k)s is 156 days. Since 2017: 244 days, versus 145 days for all cleared 510(k)s in the same product codes.
What devices does Enraf-Nonius, B.V. make?
Its most frequent FDA product codes are GXY (Electrode, Cutaneous, 1); IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, 1); IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat, 1).
Has Enraf-Nonius, B.V. had device recalls?
openFDA lists no recalls under a recalling firm name matching Enraf-Nonius, B.V. Related entities may recall under other names.
Next steps
- See all 5 Enraf-Nonius, B.V. clearances with predicates and recalls
- Run predicate analysis for product code GXY, Enraf-Nonius, B.V.'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.