Cleared Traditional

K140572 - MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR

K140572 is an FDA 510(k) clearance for MICROLIFE UPPER ARM AUTOMATIC DIGITAL B..., manufactured by Microlife Intellectual Property GmbH, Switzerland. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K140572 · Microlife Intellectual Property GmbH, Switzerland · Cardiovascular device
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Jul 2014
Decision
118d
Days
Class 2
Risk

K140572 is an FDA 510(k) clearance for the MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Microlife Intellectual Property GmbH, Switzerland (Great Neck, US). The FDA issued a Cleared decision on July 2, 2014 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 Microlife Intellectual Property GmbH, Switzerland devices

FDA 510(k) Submission Details - K140572

510(k) Number K140572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2014
Decision Date July 02, 2014
Days to Decision 118 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
7d faster than avg
Panel avg: 125d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

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