510(k) Report

FDA applicant

Theragenics Corp.

Buford, GA5 decisions1987–20111 recall

FDA records 5 decisions for Theragenics Corp. (Buford, GA) from 1987 to 2011: 5 510(k) clearances. Most are in product codes KXK (Source, Brachytherapy, Radionuclide) and IWI (Source, Isotope, Sealed, Gold, Titanium…). Its devices cite 9 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

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

FDA decisions per year

1in 2011

2007: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • KXKSource, Brachytherapy, Radionuclide4decisions
  • IWISource, Isotope, Sealed, Gold, Titanium, Platinum1decision

Whose devices does it build on?

Its devices cite 9 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 1 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.

  • K010283Theraseed (R) Palladium-103 Implant; Model 200Theragenics Corp. · 20016cite it
  • K874787Modified Palladium Seed Model 100Theragenics Corp. · 19874cite it
  • K043596Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp. · 20052cite it

What has FDA decided for it lately?

  • K103319I-SEEDTheragenics Corp. · 2011
  • K072296Poiint of Care Stranding System, Mode 1004-00Theragenics Corp. · 20071 recall
  • K043596Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp. · 2005
  • K010283Theraseed (R) Palladium-103 Implant; Model 200Theragenics Corp. · 2001
  • K874787Modified Palladium Seed Model 100Theragenics Corp. · 1987

All 5 as Theragenics Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K072296Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138…Dec 8, 2008