Cleared Traditional

Automated ankle brachial pressure index measuring device, MESI mTABLET system (K201046) - FDA 510(k) Clearance

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

K201046 · Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · Cardiovascular device
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Dec 2020
Decision
234d
Days
Class 2
Risk

K201046 is an FDA 510(k) clearance for the Automated ankle brachial pressure index measuring device, MESI mTABLET system. Classified as Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM), Class II - Special Controls.

Submitted by Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. (Ljubljana, SI). The FDA issued a Cleared decision on December 11, 2020 after a review of 234 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2780 - 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 Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. devices

Submission Details

510(k) Number K201046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2020
Decision Date December 11, 2020
Days to Decision 234 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
109d slower than avg
Panel avg: 125d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2780
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

Paladin Medical, Inc.
Elaine Duncan

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 - JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

All 52
Devices cleared under the same product code (JOM) and FDA review panel - the closest regulatory comparables to K201046.
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K200567 · Arterial Stiffness, Inc. · Feb 2021
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K191266 · Medeia, Inc. · Jan 2020
Automated ankle brachial pressure index measuring device
K172655 · Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. · Jan 2018