510(k) Report

FDA applicant

Linde Medical Sensors AG

Basel, CH4 decisions1999–20050 recalls

FDA records 4 decisions for Linde Medical Sensors AG (Basel, CH) from 1999 to 2005: 4 510(k) clearances. Most are in product codes KLK (Monitor, Oxygen, Cutaneous, For Infant Not…) and LKD (Monitor, Carbon-Dioxide, Cutaneous). Its devices cite 4 predicates, 2 of them its own earlier devices. 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, anesthesiology panel, where it files most

How often FDA has decided Linde Medical Sensors AG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Linde Medical Sensors AG since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Linde Medical Sensors AG 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?

  • KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia2decisions
  • LKDMonitor, Carbon-Dioxide, Cutaneous1decision
  • DOARadioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.1decision

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K991644Microgas 7650 Transcutaneous MonitorLinde Medical Sensors AG · 19992cite it
  • K003943Microgas 7650 Transcutaneous MonitorLinde Medical Sensors AG · 20012cite it
  • K043357Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009Linde Medical Sensors AG · 20051cites it
  • K032291Tosca PCO2, SPO2 and Pulse Rate Monitoring SystemLinde Medical Sensors AG · 20041cites it

What has FDA decided for it lately?

  • K043357Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009Linde Medical Sensors AG · 2005
  • K032291Tosca PCO2, SPO2 and Pulse Rate Monitoring SystemLinde Medical Sensors AG · 2004
  • K003943Microgas 7650 Transcutaneous MonitorLinde Medical Sensors AG · 2001
  • K991644Microgas 7650 Transcutaneous MonitorLinde Medical Sensors AG · 1999

All 4 as Linde Medical Sensors AG →

Other applicant names beginning “Linde”

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

Linde Div. Union Carbide Corp. 6Linde Gas & Equipment, Inc. 3Linde Gas Therapeutics 2Linde Healthcare AB 1Linde Gas North America, LLC 1