510(k) Report

FDA applicant

Cardinal Health Germany 234 GmbH

Palm Springs, CA2 decisions2008–20090 recalls

FDA records 2 decisions for Cardinal Health Germany 234 GmbH (Palm Springs, CA) from 2008 to 2009: 2 510(k) clearances. Most are in product codes BZG (Spirometer, Diagnostic) and BTY (Calculator, Predicted Values, Pulmonary Function). Its devices cite 3 predicates, 0 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 Cardinal Health Germany 234 GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2008: 12009: 1
2008high 1 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Cardinal Health Germany 234 GmbH by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardinal Health Germany 234 GmbH’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?

  • BZGSpirometer, Diagnostic1decision
  • BTYCalculator, Predicted Values, Pulmonary Function1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K082539Masterscope, Masterscope Ecg, Masterscope CTCardinal Health Germany 234 GmbH · 20083cite it
  • K090486Asthma Monitor Model, AM1Cardinal Health Germany 234 GmbH · 20092cite it

What has FDA decided for it lately?

  • K090486Asthma Monitor Model, AM1Cardinal Health Germany 234 GmbH · 2009
  • K082539Masterscope, Masterscope Ecg, Masterscope CTCardinal Health Germany 234 GmbH · 2008

All 2 as Cardinal Health Germany 234 GmbH →

Other applicant names beginning “Cardinal”

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

Cardinal Health, Inc. 28Cardinal Health200, LLC 26Cardinal Health, Alaris Products 9Cardinal Health-Medical Products and Services 6Cardinal Health 207, Inc. 5Cardinal Spine, LLC 4Cardinal Health 200, Inc. 4Cardinal Health 303,Inc. 4Cardinal Scale Mfg. Co. 1