510(k) Report

FDA applicant

Barrx Medical, Incorporated

Sunnyvale, CA16 decisions2005–20122 recalls

FDA records 16 decisions for Barrx Medical, Incorporated (Sunnyvale, CA) from 2005 to 2012: 16 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 43 predicates, 33 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Barrx Medical, Inc.”.

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 Barrx Medical, Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2007: 12008: 22009: 32010: 32012: 2
2007high 3 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2012

2011: 12012: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Barrx Medical, Incorporated 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 & Accessories16decisions

Whose devices does it build on?

Its devices cite 43 predicates; 33 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 46 times; 33 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.

  • K051168Barrx Halo 360 System, Model 1100C-115ABarrx Medical, Incorporated · 20059cite it
  • K060169Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation Catheter, Models…Barrx Medical, Incorporated · 20066cite it
  • K062723HALO90 Coagulation CatheterBarrx Medical, Incorporated · 20065cite it
  • K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 20105cite it
  • K083737Halo Ablation CatheterBarrx Medical, Incorporated · 20094cite it
  • K112454HALO60 Ablation CatheterBarrx Medical, Inc. · 20123cite it

What has FDA decided for it lately?

  • K120431HALO90 Ultra Ablation CatheterBarrx Medical, Inc. · 2012
  • K112454HALO60 Ablation CatheterBarrx Medical, Inc. · 2012
  • K101111Halo Ablation Catheter Model 90-9100, HALO90 Ultra Ablation Catheter Model 90-9200Barrx Medical, Inc. · 20101 recall
  • K093855Halo 360 & Sizing Balloon, Model 3441CBarrx Medical, Incorporated · 2010
  • K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010
  • K092487Haloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated · 20091 recall
  • K083737Halo Ablation CatheterBarrx Medical, Incorporated · 2009
  • K083711Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22, 32041-25, 32041-28…Barrx Medical, Incorporated · 2009

All 13 as Barrx Medical, Incorporated →All 3 as Barrx Medical, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K092487HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead…Aug 3, 2012Class II
  • K101111HALO Ultra Ablation Catheter: Rx only; for use only with the Halo Flex Energy generator…May 25, 2011