Cleared Traditional

CLEWICU System

K233216 · Clew Medical , Ltd. · Cardiovascular
Jan 2024
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K233216 is an FDA 510(k) clearance for the CLEWICU System, a Medium-term Adjunctive Predictive Cardiovascular Indicator (Class II — Special Controls, product code QNL), submitted by Clew Medical , Ltd. (Poleg, IL). The FDA issued a Cleared decision on January 13, 2024, 107 days after receiving the submission on September 28, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2210.

Submission Details

510(k) Number K233216 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2023
Decision Date January 13, 2024
Days to Decision 107 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QNL — Medium-term Adjunctive Predictive Cardiovascular Indicator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2210
Definition The Adjunctive Predictive Cardiovascular Indicator Is A Prescription Device That Uses Software Algorithms To Analyze Cardiovascular Vital Signs And Predict Future Cardiovascular Status Or Events Within A Defined Medium-term Period. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy.