Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nucletron Corporation · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
94 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103515 | EQUAL DOSE | Nucletron Corporation | 2011-09-15 | 289 | 0 |
| K090706 | ONCENTRA SIMULATION 2.3 | Nucletron Corporation | 2009-06-15 | 90 | 0 |
| K091154 | UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 11 | Nucletron Corporation | 2009-05-18 | 27 | 0 |
| K082642 | ONCENTRA RT VIEWER 1.0 | Nucletron Corporation | 2008-11-07 | 57 | 0 |
| K080934 | VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDL | Nucletron Corporation | 2008-05-28 | 56 | 0 |
| K081281 | OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) | Nucletron Corporation | 2008-05-20 | 14 | 2 |
| K080871 | TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEED | Nucletron Corporation | 2008-04-29 | 29 | 0 |
| K080929 | ONCENTRA GYN | Nucletron Corporation | 2008-04-16 | 15 | 0 |
| K073273 | EQUAL DOSE 1.0 | Nucletron Corporation | 2007-12-11 | 20 | 0 |
| K073107 | VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 | Nucletron Corporation | 2007-12-07 | 35 | 0 |
| K061354 | MICROSELECTRON V3, MODEL 106.990 | Nucletron Corporation | 2006-08-17 | 94 | 0 |
| K060349 | PROGUIDE NEEDLE SET | Nucletron Corporation | 2006-03-10 | 28 | 0 |
| K052228 | SMIT SLEEVE | Nucletron Corporation | 2005-11-09 | 85 | 0 |
| K052361 | SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM | Nucletron Corporation | 2005-10-24 | 56 | 0 |
| K033470 | SIMULIX EVOLUTION | Nucletron Corporation | 2004-02-04 | 93 | 0 |
| K032372 | NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 | Nucletron Corporation | 2003-08-15 | 14 | 0 |
| K022739 | REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), M | Nucletron Corporation | 2002-10-25 | 67 | 0 |
| K022741 | SPOT PRO (220V), MODEL 131.099 | Nucletron Corporation | 2002-10-24 | 66 | 0 |
| K022635 | KUSKE BREAST APPLICATOR SET, MODEL 189.006 | Nucletron Corporation | 2002-09-06 | 29 | 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