510(k) Report

FDA applicant

Don Tay Industries

New Berlin, WI1 decision1997–19970 recalls

FDA records 1 decision for Don Tay Industries (New Berlin, WI) in 1997: 1 510(k) clearance. All are in product code DRX (Electrode, Electrocardiograph). 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 Don Tay Industries’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Don Tay Industries since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Don Tay Industries’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