Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nucletron B.V. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
161 daysmedian FDA review time
260 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262383 | LumenCare Azure | Nucletron B.V. | 2026-07-24 | 11 | 0 |
| K251037 | Rectal Applicator | Nucletron B.V. | 2025-12-19 | 260 | 0 |
| K213942 | Esteya | Nucletron B.V. | 2022-01-11 | 25 | 0 |
| K201272 | Geneva | Nucletron B.V. | 2020-07-16 | 65 | 1 |
| K161688 | Advanced Gynecological Applicator | Nucletron B.V. | 2017-01-27 | 221 | 1 |
| K151272 | Henschke Titanium Applicator Set | Nucletron B.V. | 2015-06-23 | 41 | 0 |
| K142439 | Martinez Prostate Template Set | Nucletron B.V. | 2015-03-10 | 193 | 0 |
| K140803 | LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM | Nucletron B.V. | 2014-06-26 | 87 | 0 |
| K132816 | ONCENTRA BRACHY | Nucletron B.V. | 2014-06-13 | 277 | 1 |
| K132889 | FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR | Nucletron B.V. | 2014-02-26 | 163 | 1 |
| K132874 | LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM | Nucletron B.V. | 2014-02-21 | 161 | 0 |
| K132092 | ESTEYA | Nucletron B.V. | 2013-09-26 | 83 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda