Data / Medical devices / Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) (DRT): 78 FDA-registered makers in 21 countries

78 establishments in 21 countries are registered with the FDA to make Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) (product code DRT, Class 2, 21 CFR 870.2300). 18 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 341 510(k) clearances under this code, the latest on October 15, 2026, and lists 10 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

DRT

Device class

2

Regulation

870.2300

Medical specialty

Cardiovascular

Makers by country

Makers of Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.