# K233521: QT Ecg (QTERD100)

- Pathway: 510(k) (Special)
- Applicant: QT Medical, Inc.
- Decided: Dec 6, 2023 after 35 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: 8 generations back to K963725 (1997). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220795: QT ECG, QT Medical, Inc. (2022) Summary page 4.

## Indications for use
The QT ECG System is intended to acquire, record and process an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology to a cell-phone or mobile device, then to a remote location. The QT ECG System is indicated for use on infants, children and adults. It is designed to be operated by adults in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing homes, skilled nursing facilities), and in professional healthcare facilities (such as clinics, hospitals, and ambulances) to record and transmit a 12- lead ECG and rhythm strip in near real-time to enable review at a physician's office, hospital or other medical receiving centers.

Source page: https://510kreport.com/device/K233521
Methodology: https://510kreport.com/methodology