# K071228: Fidelity 200 Cardiac Event Recorder

- Pathway: 510(k) (Abbreviated)
- Applicant: Signalife, Inc.
- Decided: Nov 21, 2007 after 202 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 K963725 (1997). 3 ancestors in all.
32 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010945: Heartcard, Model 5258, Instromedix (2001) Summary page 1.
- K963725: Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified), Card Guard, Ltd. (1997) Summary page 1.
- K012223: CG-2211 Selfcheck Ecg Transmitter, Card Guard Scientific Survival, Ltd. (2001) Summary page 1.

## Most influential descendants
- K121628: Epi Mini Ecg Portable Health Monitoring System (Epi Mini) (2013), 31 descendants of its own
- K143513: ZIO SR ECG Monitoring Service (2015), 30 descendants of its own
- K163512: Zio AT ECG Monitoring System (2017), 18 descendants of its own
- K181502: Zio AT ECG Monitoring System, ZEUS System (2018), 12 descendants of its own
- K210822: DeepRhythmAI (2022), 6 descendants of its own

## Indications for use
The Signalife Fidelity 200 Cardiac Event Recorder is a battery operated; user-activated ECG event recorder and transmitter intended to record an ECG by patients who subscribe for the service. This allows users to record and transmit their ECG data to medical professionals via a communication device to a cardiac monitoring center. The Signalife Fidelity 200 Cardiac Event Recorder is intended for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal cardiac rhythms: Skipped beats, Pounding heart (Palpitations), Heart racing or irregular pulse, Lightheadedness or Faintness, History of Arrhythmia

Source page: https://510kreport.com/device/K071228
Methodology: https://510kreport.com/methodology