# K251218: SafeBeat Rx App

- Pathway: 510(k) (Traditional)
- Applicant: SafeBeat Rx, Inc.
- Decided: Feb 6, 2026 after 291 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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 K003621 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170568: CardioLogs ECG Analysis Platform, Cardiologs Technologies (2017) Summary page 5.

## Indications for use
The SafeBeat Rx App analyzes ECG data recorded in compatible formats. This ECG signal may originate from a full 12-lead ECG or a reduced lead set ECG. The device provides ECG signal processing and provisional analysis, including interval measurements (QT interval, QTc, ORS duration, heart rate, and RR interval), along with visible display of ORS onset (Q-start), R-peak, and ORS offset (S-end). The SafeBeat Rx App can electronically interface with, and perform analysis of, data transferred from other computer-based ECG systems, such as an ECG management system. The SafeBeat Rx App does not provide real-time ECG display, continuous monitoring, or alarm functions. The device is not for use in life-supporting or sustaining systems or ECG monitor and alarm devices. The SafeBeat Rx App ECG analysis is intended for adult patient populations (18 years and older). SafeBeat Rx App provisional ECG analysis is not intended to be the sole means of diagnosis. The SafeBea Rx App is not validated for use in lead I alone. The SafeBeat Rx App is intended to be used on an advisory basis only by qualified healthcare personnel to evaluate provisional ECG data. ECG data should be reviewed in conjunction with the patient's clinical history, symptoms, and/or other diagnostic tests, and the professional clinical judgement of the qualified healthcare provider. The SafeBeat Rx App can be used in a professional healthcare environment such as a hospital , clinic or similarly equipped facility. The SafeBeat Rx App has an optional long term monitoring workflow intended for monitoring and evaluating a patient's home acquired ECG. The software workflow that is intended for use in the professional healthcare environment should not be used in the home environment to adjust QT prolonQinQ medications as is contraindicated for applicable druQs.

Source page: https://510kreport.com/device/K251218
Methodology: https://510kreport.com/methodology