510(k) Report

FDA applicant

Sun Nuclear Corp.

Melbourne, FL24 decisions1988–20170 recalls

FDA records 24 decisions for Sun Nuclear Corp. (Melbourne, FL) from 1988 to 2017: 24 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and KPT (Calibrator, Dose, Radionuclide). Since 2016 its 510(k)s took a median of 122 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 8 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sun Nuclear Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Sun Nuclear Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2009: 12010: 12012: 12013: 32014: 32015: 22016: 22017: 1
2007high 3 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sun Nuclear Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sun Nuclear Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IYEAccelerator, Linear, Medical19decisions
  • KPTCalibrator, Dose, Radionuclide2decisions
  • KXKSource, Brachytherapy, Radionuclide1decision
  • LHNSystem, Radiation Therapy, Charged-Particle, Medical1decision
  • LNHSystem, Nuclear Magnetic Resonance Imaging1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 122 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 97 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 19 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K141800PerfractionSun Nuclear Corporation · 20144cite it
  • K131466MAPCHECK2, ArccheckSun Nuclear Corporation · 20133cite it
  • K011332RF-Ivd Wireless Dosimeter-Model 1133Sun Nuclear Corp. · 20012cite it
  • K002444Precision Dosimetry Electrometer, Model 1010 or 206Sun Nuclear Corp. · 20002cite it
  • K170307SunCHECKSun Nuclear Corporation · 20171cites it
  • K161946DoseCHECKSun Nuclear Corporation · 20161cites it

What has FDA decided for it lately?

  • K170307SunCHECKSun Nuclear Corporation · 2017
  • K161946DoseCHECKSun Nuclear Corporation · 2016
  • K160057ArcCHECK-MRSun Nuclear Corporation · 2016
  • K142617ArcCHECKSun Nuclear Corporation · 2015
  • K150848Dose CalculatorSun Nuclear Corporation · 2015
  • K142431WaterProof PROFILERSun Nuclear Corporation · 2014
  • K142142Quality ReportsSun Nuclear Corporation · 2014
  • K141800PerfractionSun Nuclear Corporation · 2014

All 13 as Sun Nuclear Corp. →All 11 as Sun Nuclear Corporation →