Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sun Nuclear Corp. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
111 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112981 | SUN 125C IONIZATION CHAMBER | Sun Nuclear Corp. | 2012-01-25 | 111 | 0 |
| K101992 | 3D SCANNER, MODEL 1230 | Sun Nuclear Corp. | 2010-10-01 | 78 | 0 |
| K092019 | MODEL 1014 PC ELECTROMETER | Sun Nuclear Corp. | 2009-09-15 | 71 | 0 |
| K063021 | PROFILER 2 | Sun Nuclear Corp. | 2006-11-22 | 51 | 0 |
| K051921 | THE EDGE DETECTOR, MODEL 1118 | Sun Nuclear Corp. | 2005-07-27 | 12 | 0 |
| K013689 | RE-ENTRANT CHAMBER | Sun Nuclear Corp. | 2002-07-02 | 238 | 0 |
| K021463 | MODEL 1133 IVD PC VERSION | Sun Nuclear Corp. | 2002-06-06 | 30 | 0 |
| K011332 | RF-IVD WIRELESS DOSIMETER-MODEL 1133 | Sun Nuclear Corp. | 2001-07-26 | 85 | 0 |
| K011466 | QED DIODE DETECTORS, MODELS 1112-1116 | Sun Nuclear Corp. | 2001-06-06 | 23 | 0 |
| K010449 | IVD (IN VIVO DOSIMETER), MODEL 1131 | Sun Nuclear Corp. | 2001-05-04 | 78 | 0 |
| K002446 | RE-ENTRANT CHAMBER, MODEL 1008 OR 44D | Sun Nuclear Corp. | 2000-10-23 | 75 | 0 |
| K002444 | PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206 | Sun Nuclear Corp. | 2000-10-18 | 70 | 0 |
| K880272 | CAL/RAD UPGRADE MODEL 1030 | Sun Nuclear Corp. | 1988-02-29 | 39 | 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