FDA applicant

Healthdyne, Inc.

Marietta, GA35 decisions1978–19951 recall

FDA records 35 decisions for Healthdyne, Inc. (Marietta, GA) from 1978 to 1995: 35 510(k) clearances. Most are in product codes BZQ (Monitor, Breathing Frequency) and CBK (Ventilator, Continuous, Facility Use). 1 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 Healthdyne, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Healthdyne, Inc. since 2007.

Recalls per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Healthdyne, 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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Other applicant names beginning “Healthdyne”

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

Healthdyne Technologies, Inc. 9 Healthdyne Cardiovascular, Inc. 5

Healthdyne, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Healthdyne”