510(k) · Cardiovascular

RhythmAnalytics

by Biofourmis Singapore Pte. Ltd.

RhythmAnalytics is an AI-enabled medical device from Biofourmis Singapore Pte. Ltd. that the U.S. FDA cleared through 510(k) K182344 on March 7, 2019. Its lead review panel is Cardiovascular and its primary product code is DQK (Computer, Diagnostic, Programmable).

See also FDA-cleared AI cardiovascular devices in 2019, all FDA AI clearances in 2019, top cardiovascular AI devices.

Key facts

Submission numberK182344
Pathway510(k)
Date of final decision
Company (FDA list)Biofourmis Singapore Pte. Ltd.
Lead review panelCardiovascular
Primary product codeDQK — Computer, Diagnostic, Programmable
Applicant (openFDA)Biofourmis Singapore Pte., Ltd.
Applicant locationSingapore, SG
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. RhythmAnalytics went through this pathway (K182344).

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 #3 of 28 under that code. Biofourmis Singapore Pte. Ltd. has 2 AI-enabled devices 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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