510(k) · Cardiovascular

CLEWICU System (ClewICUServer and ClewICUnitor)

by CLEW Medical Ltd.

CLEWICU System (ClewICUServer and ClewICUnitor) is an AI-enabled medical device from CLEW Medical Ltd. that the U.S. FDA cleared through 510(k) K200717 on January 9, 2021. Its lead review panel is Cardiovascular and its primary product code is QNL (Medium-Term Adjunctive Predictive Cardiovascular Indicator).

See also FDA-cleared AI cardiovascular devices in 2021, all FDA AI clearances in 2021, top cardiovascular AI devices.

Key facts

Submission numberK200717
Pathway510(k)
Date of final decision
Company (FDA list)CLEW Medical Ltd.
Lead review panelCardiovascular
Primary product codeQNL — Medium-Term Adjunctive Predictive Cardiovascular Indicator
Applicant (openFDA)Clew Medical , Ltd.
Applicant locationNetanya, IL
Device classClass 2
Regulation number21 CFR 870.2210
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. CLEWICU System (ClewICUServer and ClewICUnitor) went through this pathway (K200717).

openFDA lists it as a Class 2 device under 21 CFR 870.2210. Class II devices are moderate risk and are subject to general and special controls.

Product code QNL covers 5 devices on the FDA AI list. By decision date, this device is #1 of 5 under that code. CLEW Medical 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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