Nucletron B.V.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Nucletron B.V.” (first 2013, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 124 days. Since 2017 the median was 65 days, against 124 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 83 |
| 2014 | 4 | 162 |
| 2015 | 2 | 117 |
| 2016 | 0 | — |
| 2017 | 1 | 221 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 65 |
| 2021 | 0 | — |
| 2022 | 1 | 25 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 260 |
| 2026 | 1 | 11 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nucletron B.V. took a median 65 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 9 | 9 |
| JAD | System, Therapeutic, X-Ray | 2 | 2 |
| MUJ | System, Planning, Radiation Therapy Treatment | 1 | 1 |
Review panels
- Radiology (12)
Most recent Nucletron B.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262383 | LumenCare Azure | JAQ | 2026-07-24 | 11 |
| K251037 | Rectal Applicator | JAQ | 2025-12-19 | 260 |
| K213942 | Esteya | JAD | 2022-01-11 | 25 |
| K201272 | Geneva | JAQ | 2020-07-16 | 65 |
| K161688 | Advanced Gynecological Applicator | JAQ | 2017-01-27 | 221 |
| K151272 | Henschke Titanium Applicator Set | JAQ | 2015-06-23 | 41 |
| K142439 | Martinez Prostate Template Set | JAQ | 2015-03-10 | 193 |
| K140803 | LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM | JAQ | 2014-06-26 | 87 |
| K132816 | ONCENTRA BRACHY | MUJ | 2014-06-13 | 277 |
| K132889 | FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM) | JAQ | 2014-02-26 | 163 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nucletron B.V..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Nucletron Corp. (49 510(k)s)
- Nucletron Mfg. Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nucletron B.V.?
FDA lists 12 510(k) clearances under the applicant name “Nucletron B.V.” (first 2013, latest 2026), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nucletron B.V.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nucletron B.V. is 124 days. Since 2017: 65 days, versus 124 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nucletron B.V.?
The most frequent FDA product codes under this applicant name are JAQ (System, Applicator, Radionuclide, Remote-Controlled, 9); JAD (System, Therapeutic, X-Ray, 2); MUJ (System, Planning, Radiation Therapy Treatment, 1).
Next steps
- See all 12 Nucletron B.V. clearances with predicates and recalls
- Run predicate analysis for product code JAQ, Nucletron B.V.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.