510(k) Report

FDA applicant

Nucletron Corp.

Columbia, MD61 decisions1995–20268 recalls

FDA records 61 decisions for Nucletron Corp. (Columbia, MD) from 1995 to 2026: 61 510(k) clearances. Most are in product codes JAQ (System, Applicator, Radionuclide…) and MUJ (System, Planning, Radiation Therapy Treatment). Since 2016 its 510(k)s took a median of 221 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 68 predicates, 27 of them its own earlier devices. 8 recalls are linked to its devices.

FDA’s records also spell it “Nucletron Corporation”, “Nucletron B.V.”, “Nucletron”.

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 Nucletron Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 32008: 52009: 42011: 42013: 12014: 42015: 22017: 12020: 12022: 12025: 12026 (partial year): 1
2007high 5 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

3in 2026

2012: 12015: 12017: 12021: 12022: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Nucletron 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?

  • JAQSystem, Applicator, Radionuclide, Remote-Controlled35decisions
  • MUJSystem, Planning, Radiation Therapy Treatment13decisions
  • KPQSystem, Simulation, Radiation Therapy5decisions
  • IYEAccelerator, Linear, Medical4decisions
  • JADSystem, Therapeutic, X-Ray2decisions
  • KXKSource, Brachytherapy, Radionuclide1decision

Also: KPR (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 221 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 91 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 68 predicates; 27 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 68 times; 27 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.

  • K983343Plato Brachytheraphy, Model V. 14.0Nucletron Corp. · 19996cite it
  • K081281Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation · 20085cite it
  • K983341Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set, Fletcher Williamson…Nucletron Corp. · 19995cite it
  • K032372Nucletron Comfort Catheter System, Model 189.007Nucletron Corporation · 20034cite it
  • K003270Prostate Stepper Template Set, Model Part Number 189,065,189,066,189,067Nucletron Corp. · 20004cite it
  • K073107Valencia Skin Applicator Set, Model: 189.701Nucletron Corporation · 20073cite it

What has FDA decided for it lately?

  • K262383LumenCare AzureNucletron B.V. · 2026
  • K251037Rectal ApplicatorNucletron B.V. · 2025
  • K213942EsteyaNucletron B.V. · 2022
  • K201272GenevaNucletron B.V. · 20201 recall
  • K161688Advanced Gynecological ApplicatorNucletron B.V. · 20171 recall
  • K151272Henschke Titanium Applicator SetNucletron B.V. · 2015
  • K142439Martinez Prostate Template SetNucletron B.V. · 2015
  • K140803Luneray;Catheter 6F 50CM, Needle 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MMNucletron B.V. · 2014

All 27 as Nucletron Corp. →All 19 as Nucletron Corporation →All 12 as Nucletron B.V. →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K161688Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator…Apr 3, 2026Class II
  • K201272Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The…Apr 3, 2026Class II
  • K132889Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote…Apr 3, 2026Class II
  • K132816Oncentra Brachy radiation therapy planning system software.Dec 5, 2022Class II
  • K132816Oncentra Brachy users using version 4.0 and above with Applicator Modeling license…Oct 13, 2021Class II
  • K132816Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron…Aug 10, 2017Class II

Other applicant names beginning “Nucletron”

FDA records each applicant name separately; these may or may not be the same firm.

Nucletron-Oldelft Corp. 11Nucletron Mfg. Corp. 1