# K033451: Heartrak Smart at/Heartrak SMART2

- Pathway: 510(k) (Special)
- Applicant: Universal Medical, Inc.
- Decided: Feb 5, 2004 after 98 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: 1 generation back to K960499 (1996). 1 ancestor in all.
63 later devices descend from it; 2 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960499: Heartrak XL, Universal Medical, Inc. (1996) Summary page 2.

## Most influential descendants
- K071130: Heartrak AF (2008), 61 descendants of its own
- 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

## Indications for use
Used as a supplement to Holter Monitoring to document infrequent/transient symptoms such as lightheadedness, chest discomfort, palpitations, pre-syncope and syncope events.

Source page: https://510kreport.com/device/K033451
Methodology: https://510kreport.com/methodology