Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nucletron-Oldelft Corp. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
189 daysmedian FDA review time
358 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953946 | MICROSELECTRON-HDR VERSION 2 | Nucletron-Oldelft Corp. | 1996-08-13 | 358 | 0 |
| K953831 | N 800 HF | Nucletron-Oldelft Corp. | 1995-09-08 | 24 | 0 |
| K925956 | MICROSELECTRON - HDR FOR MOBILE ENVIRONMENT | Nucletron-Oldelft Corp. | 1993-11-19 | 360 | 0 |
| K926407 | MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM | Nucletron-Oldelft Corp. | 1993-03-31 | 100 | 0 |
| K921991 | PLATO RADIATION THERAPY PLANNING SYSTEM | Nucletron-Oldelft Corp. | 1992-11-27 | 213 | 0 |
| K915622 | PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM | Nucletron-Oldelft Corp. | 1992-09-25 | 284 | 0 |
| K911612 | NUCLETRON PLANNING SYSTEM | Nucletron-Oldelft Corp. | 1991-06-13 | 63 | 0 |
| K902533 | PULSED SELECTRON | Nucletron-Oldelft Corp. | 1990-10-12 | 126 | 0 |
| K864210 | MICROSELECTRON-HDR (HIGH DOSE RATE) | Nucletron-Oldelft Corp. | 1986-11-26 | 29 | 0 |
| K853912 | MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS | Nucletron-Oldelft Corp. | 1986-05-21 | 243 | 0 |
| K852842 | SELECTRON HDR REMOTE AFTERLOADER | Nucletron-Oldelft Corp. | 1986-01-10 | 189 | 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