Cleared Traditional

CSF-4 (CSF-4) (K232445) - FDA 510(k) Clearance

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

K232445 · Cardiacsense · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2024
Decision
262d
Days
Class 2
Risk

K232445 is an FDA 510(k) clearance for the CSF-4 (CSF-4). Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cardiacsense (Caesarea, IL). The FDA issued a Cleared decision on May 2, 2024 after a review of 262 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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.

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Submission Details

510(k) Number K232445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2023
Decision Date May 02, 2024
Days to Decision 262 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
137d slower than avg
Panel avg: 125d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 133
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K232445.
MEDIBLU ECG SYSTEM
K233266 · Mediblu Medical, LLC · Jun 2024
Impala
K232035 · AliveCor, Inc. · Jun 2024
Electrocardiograph, model: ECG301
K232816 · Shenzhen LE Medical Technology Co., Ltd. · Jun 2024
MCG-S (AM1000)
K232823 · Amcg Co., Ltd. · Apr 2024
Cardio Q50, Cardio Q70
K231160 · Bionet Co., Ltd. · Dec 2023
CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H
K230834 · Trismed Co., Ltd. · Nov 2023