FDA applicant

Cardiophonics, Inc.

Port Jefferson Station, NY1 decision1996–19960 recalls

FDA records 1 decision for Cardiophonics, Inc. (Port Jefferson Station, NY) in 1996: 1 510(k) clearance. All are in product code DQC (Phonocardiograph). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Cardiophonics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cardiophonics, 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

Cardiophonics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?