510(k) Report

FDA applicant

Luther Medical Products, Inc.

Tustin, CA17 decisions1980–199810 recalls

FDA records 17 decisions for Luther Medical Products, Inc. (Tustin, CA) from 1980 to 1998: 17 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and LJS (Catheter, Intravascular, Therapeutic…). Its devices cite 3 predicates, 2 of them its own earlier devices. 10 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 hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Luther Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Luther Medical Products, 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?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days6decisions
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days4decisions
  • DYBIntroducer, Catheter2decisions
  • GCDConnector, Catheter1decision
  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular1decision
  • DQRCannula, Catheter1decision

Also: LKX (1), DQX (1).

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 2 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.

  • K920755L-Cath Peel Away System CatheterLuther Medical Products, Inc. · 19932cite it
  • K801575L-Cath Intravenous Placement UnitLuther Medical Products, Inc. · 19801cites it
  • K980090Onecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM)Luther Medical Products, Inc. · 19981cites it
  • K930473Onecath L-Cath Catheter SystemLuther Medical Products, Inc. · 19941cites it
  • K924562Catheter IntroducerLuther Medical Products, Inc. · 19931cites it
  • K924968L-Cath Peel-Away Catheter SystemLuther Medical Products, Inc. · 19931cites it

What has FDA decided for it lately?

  • K982797Blunt T-Peel Introducer Model Number PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICBLuther Medical Products, Inc. · 1998
  • K980090Onecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM)Luther Medical Products, Inc. · 1998
  • K974543L-Cath Modified Seldinger Technique Insertion/Catheter Exchange Kit PE-MST24-24 GA. Kit, L-Cath Modified…Luther Medical Products, Inc. · 1998
  • K940198L-Cath Connector AssemblyLuther Medical Products, Inc. · 1994
  • K942103L-Cath Catheter System - Port L-CathLuther Medical Products, Inc. · 1994
  • K930473Onecath L-Cath Catheter SystemLuther Medical Products, Inc. · 1994
  • K925236L Cath (R) Catheter SystemLuther Medical Products, Inc. · 1994
  • K920755L-Cath Peel Away System CatheterLuther Medical Products, Inc. · 199310 recalls

All 17 as Luther Medical Products, Inc. →

What has been recalled?

10 recalls linked to its devices; the latest:

  • K92075516 G / 5F Dual Lumen L-Cath Complete Kit with IntrosyteMar 25, 2005
  • K92075516 G / 5F Dual Lumen L-Cath Basic Kit with Insyte AutoguardMar 25, 2005
  • K92075516 G / 5F Dual Lumen L-Cath complete kit with U-WingMar 25, 2005
  • K92075516 G / 5F Dual Lumen L-Cath catheter only.Mar 25, 2005
  • K92075516 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte AutoguardMar 25, 2005
  • K92075516 G / 5F Dual Lumen L-Cath Basic Kit with IntrosyteMar 25, 2005

Other applicant names beginning “Luther”

FDA records each applicant name separately; these may or may not be the same firm.

Luther Needlesafe Products, Inc. 2Luther Research Partners 1