510(k) Report

FDA applicant

Cirrus Medical,Inc.

La Jolla, CA1 decision1995–19950 recalls

FDA records 1 decision for Cirrus Medical,Inc. (La Jolla, CA) in 1995: 1 510(k) clearance. All are in product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2)…). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Cirrus Medical,Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cirrus Medical,Inc. 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?

  • CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph1decision

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.

  • K954482Sendx 100 PH, Blood Gas & Electrolyte Analysis SystemCirrus Medical,Inc. · 19953cite it

What has FDA decided for it lately?

  • K954482Sendx 100 PH, Blood Gas & Electrolyte Analysis SystemCirrus Medical,Inc. · 1995

The one decision as Cirrus Medical,Inc. →

Other applicant names beginning “Cirrus”

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

Cirrus Diagnostics, Inc. 10