# K030535: Ekgcard System

- Pathway: 510(k) (Traditional)
- Applicant: Qrs Diagnostic, LLC
- Decided: Jun 11, 2003 after 111 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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 K974351 (1998). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974351: Biolog 3000 Electrocardiograph, Micromedical, Inc. (1998) Summary page 2.
- K974220: Micromedical 12 Lead Simultaneous Cable, Micromedical, Inc. (1998) Summary page 2.

## Most influential descendants
- K050674: Physioglove ES (2006), 2 descendants of its own
- K103791: Physioglove ES with Ecg Analysis (2011), 1 descendant of its own
- K103427: Mobileecg System (2011), 1 descendant of its own
- K142349: TM eCloud ECG Analysis System (2015), 0 descendants of its own
- K133703: Physioglove ET System (2014), 0 descendants of its own

## Indications for use
Diagnostic ECG for 12 Channel Resting ECG - Patient Population: Male/Female/Pcdiatric to Adult - Environment of Use: Hospital, Clinic, and Home Use - Prescription Device by a Physician

Source page: https://510kreport.com/device/K030535
Methodology: https://510kreport.com/methodology