Cleared Traditional

K233253 - eCARTv5 Clinical Deterioration Suite (“eCART”) (FDA 510(k) Clearance)

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

K233253 · Agilemd, Inc. · Cardiovascular device
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Jun 2024
Decision
267d
Days
Class 2
Risk

K233253 is an FDA 510(k) clearance for the eCARTv5 Clinical Deterioration Suite (“eCART”). Classified as Medium-term Adjunctive Predictive Cardiovascular Indicator (product code QNL), Class II - Special Controls.

Submitted by Agilemd, Inc. (San Francisco, US). The FDA issued a Cleared decision on June 21, 2024 after a review of 267 days - an extended review cycle.

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 Agilemd, Inc. devices

Submission Details

510(k) Number K233253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2023
Decision Date June 21, 2024
Days to Decision 267 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 125d · This submission: 267d
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 Consultant

Hogan Lovells US LLP
Kelliann H. Payne

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.