Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sun Nuclear Corporation · Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

91 daysmedian FDA review time
266 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K170307SunCHECKSun Nuclear Corporation2017-10-252660
K161946DoseCHECKSun Nuclear Corporation2016-09-16630
K160057ArcCHECK-MRSun Nuclear Corporation2016-05-131220
K142617ArcCHECKSun Nuclear Corporation2015-11-204300
K150848Dose CalculatorSun Nuclear Corporation2015-05-20500
K142431WaterProof PROFILERSun Nuclear Corporation2014-12-05980
K142142QUALITY REPORTSSun Nuclear Corporation2014-12-051220
K141800PERFRACTIONSun Nuclear Corporation2014-09-26850
K1318623DVHSun Nuclear Corporation2013-08-21580
K131466MAPCHECK2, ARCCHECKSun Nuclear Corporation2013-08-20910
K131704EPIDOSESun Nuclear Corporation2013-08-05550

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