Cleared Traditional

K261580 - ZBPro Diagnostic (Version 2.0)

K261580 is an FDA 510(k) clearance for ZBPro Diagnostic (Version 2.0), manufactured by Zbeats, Inc.. The device is a Class 2 Cardiovascular device with product code MLO cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K261580 · Zbeats, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
121d
Days
Class 2
Risk

K261580 is an FDA 510(k) clearance for the ZBPro Diagnostic (Version 2.0). Classified as Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO), Class II - Special Controls.

Submitted by Zbeats, Inc. (Stony Brook, US). The FDA issued a Cleared decision on September 11, 2026 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 Zbeats, Inc. devices

FDA 510(k) Submission Details - K261580

510(k) Number K261580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2026
Decision Date September 11, 2026
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MLO Device Classification - Class 2, Special Controls

Product Code MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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

Zaliance Medical Solutions, LLC
Christopher Ford

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.

Regulatory Peers - MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

All 29
Devices cleared under the same product code (MLO) and FDA review panel - the closest regulatory comparables to K261580.
Philips Holter Analysis System
K241890 · Philips Medizin Systeme B?blingen GmbH · Mar 2025
Frontier X Plus
K240794 · Fourth Frontier Technologies Pvt, Ltd. · Nov 2024
RX-1 Rhythm Express Remote Cardiac Monitoring System
K200833 · Vivaquant, Inc. · Sep 2020
CER-S
K193177 · Cardiocalm · Aug 2020
Faros Mobile
K182030 · Bittium Biosignals , Ltd. · Nov 2018
CARDIOSPY ECG HOLTER SYSTEMS
K140847 · Labtech Kft. · Dec 2014