510(k) Report

FDA applicant

Heart Rate, Inc.

Mchenry, IL1 decision1984–19840 recalls

FDA records 1 decision for Heart Rate, Inc. (Mchenry, IL) in 1984: 1 510(k) clearance. All are in product code BZQ (Monitor, Breathing Frequency). 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 Heart Rate, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Heart Rate, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Heart Rate, 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

Which product codes does it file in?

  • BZQMonitor, Breathing Frequency1decision

What has FDA decided for it lately?

  • K840488Lifecycle Aerobic Monitor 123Heart Rate, Inc. · 1984

The one decision as Heart Rate, Inc. →

Other applicant names beginning “Heart”

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

The Heart Valve Div. Medtronic Cardiovascular Surg 5Heart Sync, Inc. 5Heart Technology, Inc. 4Heart Technology Mfg., Inc. 3Heart Imaging Technologies, LLC 2Heart Alert, Inc. 1Heart Sounds, Inc. 1Heart Check Systems, Inc. 1Heart Rhythm Technologies, Inc. 1