Cleared Traditional

K233216 - CLEWICU System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K233216 is an FDA 510(k) clearance for the CLEWICU System. Classified as Medium-term Adjunctive Predictive Cardiovascular Indicator (product code QNL), Class II - Special Controls.

Submitted by Clew Medical , Ltd. (Poleg, IL). The FDA issued a Cleared decision on January 13, 2024 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2210 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Clew Medical , Ltd. devices

Submission Details

510(k) Number K233216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 125d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QNL Medium-term Adjunctive Predictive Cardiovascular Indicator
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QNL Medium-term Adjunctive Predictive Cardiovascular Indicator

Devices cleared under the same product code (QNL) and FDA review panel - the closest regulatory comparables to K233216.
eCARTv5 Clinical Deterioration Suite (“eCART”)
K233253 · Agilemd, Inc. · Jun 2024
SignalHF (IM008)
K230842 · Implicity, Inc. · Oct 2023
Global Hypoperfusion Index (GHI) Algorithm
K231038 · Edwards Lifesciences, LLC · Jul 2023
CLEWICU System (ClewICUServer and ClewICUnitor)
K200717 · Clew Medical , Ltd. · Jan 2021