# K100813: QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card Usb

- Pathway: 510(k) (Special)
- Applicant: Pulse Biomedical, Inc.
- Decided: Jul 23, 2010 after 122 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: 4 generations back to K942704 (1994). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972255: Pulse Biomedical Inc, QRS Card S-T Segment Analysis Monitoring System, Pulse Biomedical, Inc. (1998) Summary page 2.
- K080141: PC Ecg 1200W System, Norav Medical, Ltd. (2008) Summary page 2.
- K061977: Pelex-04 Wireless Electrocardiograph with Software Accessories, Pinmed, Inc. (2006) Summary page 2.
- K082077: BT3/6, BT12, Corscience GmbH & Co. KG (2008) Summary page 2.

## Most influential descendants
- K142352: CardiacLinx (2015), 0 descendants of its own

## Indications for use
This device is intended for use as a patient monitor for any patient undergoing ECG S-T Segment Analysis and/or ECG stress analysis during rest or exercise. Exercise can be performed treadmill or bicycle ergometer use. The intended use locations are either in a physician's office, hospital or rehabilitation facilities, or similar use areas. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in a hospital environment, physician's office, or similar settings. This device is not intended for home use.

Source page: https://510kreport.com/device/K100813
Methodology: https://510kreport.com/methodology