# K193296: eCordum Cardiac Monitor (eCordum CM)

- Pathway: 510(k) (Traditional)
- Applicant: Ecordum, Inc.
- Decided: Oct 30, 2020 after 338 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: 7 generations back to K882803 (1988). 12 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121197: Bodyguardian System Bodyguardian Control Unit Bodyguardian Connect, Preventice, Inc. (2012) Summary page 4.

## Most influential descendants
- K222842: V-Patch Cardiac Monitor (2022), 1 descendant of its own
- K243438: MEMO Patch M (MPT-E08R-UNC01) (2025), 0 descendants of its own
- K243003: VitalSigns 1-Lead Holter (VSH101) (2025), 0 descendants of its own

## Indications for use
The eCordumTm Cardiac Monitor is intended to record, transfer and store single-channel electrocardiogram (ECG) data via Bluetooth transmission to Bluetooth enabled devices. The monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The ECG data is intended to supplement other patient data and is not intended for automated analysis. The device has not been tested and it is not intended for pediatric use.

Source page: https://510kreport.com/device/K193296
Methodology: https://510kreport.com/methodology