# K260250: QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)

- Pathway: 510(k) (Traditional)
- Applicant: QT Medical, Inc.
- Decided: Sep 29, 2026 after 245 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: 5 generations back to K933143 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120865: Rscribe Electrocardiograph, Mortara Instrument, Inc. (2012) Summary page 5.

## Indications for use
The QCA 10/10W ECG System is a non-invasive prescription medical device intended for use by trained healthcare professionals in clinical settings (e.g., hospitals, medical clinics, physician offices). The device is intended to acquire, record, display, analyze, store, and print 12-lead ECG signals from both adult and pediatric patients (pediatric: >1 month to 21 years of age). The analysis function provides basic automated ECG measurements. The device is not intended for use as a vital signs physiological monitor.

Source page: https://510kreport.com/device/K260250
Methodology: https://510kreport.com/methodology