# K071130: Heartrak AF

- Pathway: 510(k) (Abbreviated)
- Applicant: Universal Medical, Inc.
- Decided: May 14, 2008 after 387 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K960499 (1996). 2 ancestors in all.
61 later devices descend from it; 4 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033451: Heartrak Smart at/Heartrak SMART2, Universal Medical, Inc. (2004) Summary page 2.

## Most influential descendants
- K091971: Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) System (2009), 38 descendants of its own
- K111917: Nuvant, Mobile Cardiac Telemetry (2011), 30 descendants of its own
- K113372: Nuvant, Mobilc Cardiac Telemetry (2012), 24 descendants of its own
- K133701: Nuvant MCT System (2014), 23 descendants of its own
- K163512: Zio AT ECG Monitoring System (2017), 18 descendants of its own

## Indications for use
Heartrak Smart AF is a hand-held, portable, externally applied, cardiac event recorder that is intended for transtelephonic use. Patient calls a receiving center at the hospital or physician's office from the patient's home to play back the recording. Heartrak Smart AF converts electrocardiogram (ECG) signals into audio tones which are transmitted over the telephone lines. Heartrak Smart AF does not deliver any energy, administer any drugs, or control a patient's life. Heartrak Smart AF is not a diagnostic tool and performs no diagnostic functions.

Source page: https://510kreport.com/device/K071130
Methodology: https://510kreport.com/methodology