FDA applicant

Respitrace Corp.

Ardsley, NY6 decisions1978–19860 recalls

FDA records 6 decisions for Respitrace Corp. (Ardsley, NY) from 1978 to 1986: 6 510(k) clearances. All are in product code BZK (Spirometer, Monitoring (W/Wo Alarm)). 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 Respitrace Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Respitrace Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Respitrace Corp.

Which product codes does it file in?

What has FDA decided for it lately?