510(k) Report

FDA applicant

Medifocus, Inc.

Columbia2 decisions1989–20044 recalls

FDA records 2 decisions for Medifocus, Inc. (Columbia) from 1989 to 2004: 2 original PMA approvals. Most are in product codes LNC (Applicator, Hyperthermia, Superficial…) and MEQ (System, Hyperthermia, Rf/Microwave (Benign…). 4 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Medifocus, Inc. since 2007.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medifocus, Inc. 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?

  • LNCApplicator, Hyperthermia, Superficial, Rf/Microwave1decision
  • MEQSystem, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy1decision

What has FDA decided for it lately?

  • P030006Prolieve Thermodilatation SystemMedifocus, Inc. · 20044 recalls
  • P880064Hyperthermia System 100 aMedifocus, Inc. · 1989

All 2 as Medifocus, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • P030006Prolieve Thermodilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System…Jul 20, 2009
  • P030006Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter…May 4, 2006
  • P030006Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter…Mar 22, 2006
  • P030006Prolieve Thermodilatation System, model number M0068808000, labeled in…Jul 19, 2004