510(k) Report

FDA applicant

Radiotherapeutics Corp.

Mountain View, CA12 decisions1995–200215 recalls

FDA records 12 decisions for Radiotherapeutics Corp. (Mountain View, CA) from 1995 to 2002: 12 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and JOS (Electrode, Electrosurgical). 15 recalls are linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Radiotherapeutics Corp. since 2007.

Recalls per year

3in 2012

2007: 42008: 42009: 22012: 3
2007high 4 (2007) · low 0 (2010)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories10decisions
  • JOSElectrode, Electrosurgical1decision
  • FLLContinuous Measurement Thermometer1decision

Who builds on its devices?

Later devices cite its devices 12 times; 0 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.

  • K981672Radiotherapeutics RF-2000 Radiofrequency GeneratorRadiotherapeutics Corp. · 19984cite it
  • K000241Radiotherapeutics RF 3000 Radiofrequency GeneratorRadiotherapeutics Corp. · 20003cite it
  • K012315Leveen ElectrodeRadiotherapeutics Corp. · 20012cite it
  • K962313Modified Leveen Needle ElectrodeRadiotherapeutics Corp. · 19961cites it
  • K982556Leveen Needle ElectrodeRadiotherapeutics Corp. · 20001cites it
  • K000032Leveen Needle ElectrodeRadiotherapeutics Corp. · 20001cites it

What has FDA decided for it lately?

  • K011220Leveen Reflect Monopolar/Bipolar Needle ElectrodeRadiotherapeutics Corp. · 2002
  • K012315Leveen ElectrodeRadiotherapeutics Corp. · 20012 recalls
  • K000241Radiotherapeutics RF 3000 Radiofrequency GeneratorRadiotherapeutics Corp. · 2000
  • K982556Leveen Needle ElectrodeRadiotherapeutics Corp. · 200011 recalls
  • K000032Leveen Needle ElectrodeRadiotherapeutics Corp. · 20003 recalls
  • K982854MR Compatible Leveen Needle ElectrodeRadiotherapeutics Corp. · 1998
  • K981672Radiotherapeutics RF-2000 Radiofrequency GeneratorRadiotherapeutics Corp. · 1998
  • K972441Radiotherapeutics RF Generator. Model #RF-2000Radiotherapeutics Corp. · 1997

All 12 as Radiotherapeutics Corp. →

What has been recalled?

15 recalls linked to its devices; the latest:

  • K000032LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25)…Sep 17, 2012Class II
  • K012315Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended…Sep 17, 2012Class II
  • K012315Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, monopolar…Sep 17, 2012Class II
  • K000032Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For…Jul 6, 2009
  • K000032Boston Scientific, LeVeen Needle Electrode, 25 cm, 5.0 cm, sterile; REF M001262170. For…Jul 6, 2009
  • K982556Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile, Boston…Apr 30, 2008