Cleared Traditional

K151869 - Microlife Upper Arm Automatic Digital Blood Pressure Monitor

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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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 Consultant

Mdi Consultants, Inc.
SUSAN D. GOLDSTEIN-FALK

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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 990
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K151869.
iHealth BP3L Wireless Blood Pressure Monitor
K152003 · Andon Health Co, Ltd. · Sep 2015
iHealth View BP7S Wireless Blood Pressure Wrist Monitor
K152379 · Andon Health Co, Ltd. · Sep 2015
Fully Automatic Electronic Blood Pressure Monitor
K151460 · Andon Health Co, Ltd. · Sep 2015
Full Automatic (NIBP)Blood Pressure Monitor
K150311 · Health & Life Co., Ltd. · Aug 2015
Digital Automatic Wrist Blood Pressure Monitor MD3900
K151583 · Grandway Technology (Shenzhen) Limited · Aug 2015
Digital Automatic Wrist Blood Pressure Monitor MD3200
K151587 · Grandway Technology (Shenzhen) Limited · Aug 2015