510(k) · Cardiovascular

HeartKey® Rhythm

by B-Secur Limited

HeartKey® Rhythm is an AI-enabled medical device from B-Secur Limited that the U.S. FDA cleared through 510(k) K233755 on August 16, 2024. Its lead review panel is Cardiovascular and its primary product code is DQK (Computer, Diagnostic, Programmable).

See also FDA-cleared AI cardiovascular devices in 2024, all FDA AI clearances in 2024, top cardiovascular AI devices.

Key facts

Submission numberK233755
Pathway510(k)
Date of final decision
Company (FDA list)B-Secur Limited
Lead review panelCardiovascular
Primary product codeDQK — Computer, Diagnostic, Programmable
Applicant (openFDA)B-Secur Limited
Applicant locationBelfast, GB
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. HeartKey® Rhythm went through this pathway (K233755).

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 #18 of 28 under that code. B-Secur Limited 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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