FDA applicant

Healthdyne Cardiovascular, Inc.

Irvine, CA5 decisions1989–19900 recalls

FDA records 5 decisions for Healthdyne Cardiovascular, Inc. (Irvine, CA) from 1989 to 1990: 5 510(k) clearances. Most are in product codes KXO (Monitor, Pressure, Intrauterine) and DXT (Injector And Syringe, Angiographic). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Healthdyne Cardiovascular, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Healthdyne Cardiovascular, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Healthdyne”

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

Healthdyne, Inc. 35 Healthdyne Technologies, Inc. 9

Healthdyne Cardiovascular, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Healthdyne”