510(k) · Cardiovascular

SafeBeat Rx App

by SafeBeat Rx, Inc.

SafeBeat Rx App is an AI-enabled medical device from SafeBeat Rx, Inc. that the U.S. FDA cleared through 510(k) K251218 on February 6, 2026. Its lead review panel is Cardiovascular and its primary product code is DQK (Computer, Diagnostic, Programmable).

See also FDA-cleared AI cardiovascular devices in 2026, all FDA AI clearances in 2026, top cardiovascular AI devices.

Key facts

Submission numberK251218
Pathway510(k)
Date of final decision
Company (FDA list)SafeBeat Rx, Inc.
Lead review panelCardiovascular
Primary product codeDQK — Computer, Diagnostic, Programmable
Applicant (openFDA)SafeBeat Rx, Inc.
Applicant locationSan Francisco, CA, US
Device classClass 2
Regulation number21 CFR 870.1425
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. SafeBeat Rx App went through this pathway (K251218).

openFDA lists it as a Class 2 device under 21 CFR 870.1425. Class II devices are moderate risk and are subject to general and special controls.

Product code DQK covers 28 devices on the FDA AI list. By decision date, this device is #26 of 28 under that code. SafeBeat Rx, Inc. has 1 AI-enabled device on the list, and the Cardiovascular panel accounts for 154 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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