Cleared Traditional

K151869 - Microlife Upper Arm Automatic Digital B...

K151869 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 55-day FDA review.

K151869 · Microlife Intellectual Property GmbH, Switzerland · Cardiovascular device
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Sep 2015
Decision
55d
Days
Class 2
Risk

K151869 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 (Widnau, CH). The FDA issued a Cleared decision on September 2, 2015 after a review of 55 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Microlife Intellectual Property GmbH, Switzerland devices

FDA 510(k) Submission Details - K151869

510(k) Number K151869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2015
Decision Date September 02, 2015
Days to Decision 55 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
70d faster than avg
Panel avg: 125d · This submission: 55d
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

All 566
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