Cleared Traditional

K233266 - MEDIBLU ECG SYSTEM

K233266 is an FDA 510(k) clearance for MEDIBLU ECG SYSTEM, manufactured by Mediblu Medical, LLC. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 257-day FDA review.

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

FDA 510(k) Submission Details - K233266

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.

DPS Device Classification - Class 2, Special Controls

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 283
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
K232161 · Medicalgorithmics S.A. · Jun 2024
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