# K972255: Pulse Biomedical Inc, QRS Card S-T Segment Analysis Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Pulse Biomedical, Inc.
- Decided: Jul 7, 1998 after 385 days
- Product code: LOS
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K100813: QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card Usb (2010), 1 descendant of its own
- 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 ST Segment Analysis and/or ECG Stress Analysis during resting or exercise. Exercise can be performed during treadmill or bicycle ergometer use. This device is capable of performing automatic computerized ECG Interpretation during resting condition. This device does not support automatic ECG Interpretation for neonatal use. The intended use locations are either in a physician office, hospital exercise 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 the hospital environment, physician’s office, or similar settings. This device is not intended for home use.

Source page: https://510kreport.com/device/K972255
Methodology: https://510kreport.com/methodology