510(k) · Cardiovascular

Eko Analysis Software

by Eko Devices Inc

Eko Analysis Software is an AI-enabled medical device from Eko Devices Inc that the U.S. FDA cleared through 510(k) K192004 on January 15, 2020. Its lead review panel is Cardiovascular and its primary product code is MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)).

See also FDA-cleared AI cardiovascular devices in 2020, all FDA AI clearances in 2020, top cardiovascular AI devices.

Key facts

Submission numberK192004
Pathway510(k)
Date of final decision
Company (FDA list)Eko Devices Inc
Lead review panelCardiovascular
Primary product codeMWI — Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Applicant (openFDA)Eko Devices, Inc.
Applicant locationBerkeley, CA, US
Device classClass 2
Regulation number21 CFR 870.2300
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. Eko Analysis Software went through this pathway (K192004).

openFDA lists it as a Class 2 device under 21 CFR 870.2300. Class II devices are moderate risk and are subject to general and special controls.

Product code MWI covers 5 devices on the FDA AI list. By decision date, this device is #4 of 5 under that code. Eko Devices Inc 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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