510(k) Report

FDA applicant

Lucent Medical Systems

Kirkland, WA2 decisions2000–20060 recalls

FDA records 2 decisions for Lucent Medical Systems (Kirkland, WA) from 2000 to 2006: 2 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and LJS (Catheter, Intravascular, Therapeutic…). No 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, general hospital panel, where it files most

How often FDA has decided Lucent Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lucent Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lucent Medical Systems 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?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K061240Sherlock Tip Location System (TLS) Detector and AccessoriesLucent Medical Systems · 20062cite it
  • K000997Zortran DetectorLucent Medical Systems · 20001cites it

What has FDA decided for it lately?

  • K061240Sherlock Tip Location System (TLS) Detector and AccessoriesLucent Medical Systems · 2006
  • K000997Zortran DetectorLucent Medical Systems · 2000

All 2 as Lucent Medical Systems →