510(k) Report

FDA applicant

Bicore Monitoring Systems

Irvine, CA4 decisions1990–19950 recalls

FDA records 4 decisions for Bicore Monitoring Systems (Irvine, CA) from 1990 to 1995: 4 510(k) clearances. Most are in product codes BZK (Spirometer, Monitoring (W/Wo Alarm)) and BZC (Calculator, Pulmonary Function Data). 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 Bicore Monitoring Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bicore Monitoring Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bicore Monitoring 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?

  • BZKSpirometer, Monitoring (W/Wo Alarm)1decision
  • BZCCalculator, Pulmonary Function Data1decision
  • BYRTransducer, Gas Pressure, Differential1decision
  • MODAccessory To Continuous Ventilator (Respirator)1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K900696Biore CP-100 Cardiopulmonary MonitorBicore Monitoring Systems · 19902cite it
  • K935788Bicore Smartcath Intratracheal CatheterBicore Monitoring Systems · 19952cite it

What has FDA decided for it lately?

  • K935788Bicore Smartcath Intratracheal CatheterBicore Monitoring Systems · 1995
  • K921717Bicore Smartvalve Occlusion ValveBicore Monitoring Systems · 1992
  • K900696Biore CP-100 Cardiopulmonary MonitorBicore Monitoring Systems · 1990
  • K896718Bicore Variflex (R) Flow TransducerBicore Monitoring Systems · 1990

All 4 as Bicore Monitoring Systems →