510(k) Report

FDA applicant

Hayes Products, Inc.

Mchenry, IL5 decisions1977–19790 recalls

FDA records 5 decisions for Hayes Products, Inc. (Mchenry, IL) from 1977 to 1979: 5 510(k) clearances. 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 Hayes Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hayes Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hayes Products, 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 “Hayes”

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