Cleared Traditional

MEDIBLU ECG SYSTEM (K233266) - FDA 510(k) Clearance

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

K233266 · Mediblu Medical, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
257d
Days
Class 2
Risk

K233266 is an FDA 510(k) clearance for the MEDIBLU ECG SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Mediblu Medical, LLC (Doral, US). The FDA issued a Cleared decision on June 12, 2024 after a review of 257 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.

View all Mediblu Medical, LLC devices

Submission Details

510(k) Number K233266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date June 12, 2024
Days to Decision 257 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
132d slower than avg
Panel avg: 125d · This submission: 257d
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 K233266.
Cardiac Workstation (5000)
K241556 · Philips Medizin Systeme B?blingen GmbH · Dec 2024
Masimo W1
K240229 · Masimo Corporation · Aug 2024
DeepRhythm Platform
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Impala
K232035 · AliveCor, Inc. · Jun 2024
Electrocardiograph, model: ECG301
K232816 · Shenzhen LE Medical Technology Co., Ltd. · Jun 2024
CSF-4 (CSF-4)
K232445 · Cardiacsense · May 2024