510(k) Report

FDA applicant

Lumend, Inc.

Redwood City, CA11 decisions2001–20052 recalls

FDA records 11 decisions for Lumend, Inc. (Redwood City, CA) from 2001 to 2005: 11 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and PDU (Catheter For Crossing Total Occlusions). Its devices cite 17 predicates, 10 of them its own earlier devices. 2 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Lumend, Inc. since 2007.

Recalls per year

1in 2008

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

Class I Class II/III not classified

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

Planning a device like Lumend, Inc.’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?

  • DQYCatheter, Percutaneous8decisions
  • PDUCatheter For Crossing Total Occlusions3decisions

Whose devices does it build on?

Its devices cite 17 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 26 times; 10 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.

  • K001577Outback CatheterLumend, Inc. · 20015cite it
  • K023114Lumend Frontrunner Cto CatheterLumend, Inc. · 20033cite it
  • K011562Lumend Percutaneous CatheterLumend, Inc. · 20023cite it
  • K013284Lumend Frontrunner Cto Coronary CatheterLumend, Inc. · 20023cite it
  • K033535Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc. · 20043cite it
  • K031005Lumend Frontrunner GW Cto CatheterLumend, Inc. · 20032cite it

What has FDA decided for it lately?

  • K043534Modification to Outback CatheterLumend, Inc. · 20051 recall
  • K040771Modification to Outback CatheterLumend, Inc. · 20041 recall
  • K033535Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc. · 2004
  • K032298Modification to Outback CatheterLumend, Inc. · 20032 recalls
  • K031005Lumend Frontrunner GW Cto CatheterLumend, Inc. · 2003
  • K023114Lumend Frontrunner Cto CatheterLumend, Inc. · 2003
  • K023223Modification to Lumend Frontrunner Cto CatheterLumend, Inc. · 2002
  • K013284Lumend Frontrunner Cto Coronary CatheterLumend, Inc. · 2002

All 11 as Lumend, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K001577Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD…Aug 20, 2008
  • K032298LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with…May 18, 2004