Cleared Traditional

K172498 - Microlife Upper Arm Automatic Digital B...

K172498 is an FDA 510(k) clearance for Microlife Upper Arm Automatic Digital B..., manufactured by Microlife Intellectual Property GmbH. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K172498 · Microlife Intellectual Property GmbH · Cardiovascular device
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Oct 2017
Decision
56d
Days
Class 2
Risk

K172498 is an FDA 510(k) clearance for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Microlife Intellectual Property GmbH (Widnau, CH). The FDA issued a Cleared decision on October 13, 2017 after a review of 56 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 devices

FDA 510(k) Submission Details - K172498

510(k) Number K172498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2017
Decision Date October 13, 2017
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 565
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K172498.
Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579
K170866 · Honsun (Nantong) Co., Ltd. · Feb 2018
Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312
K172896 · Shenzhen Jiacom Technology CO ., Ltd. · Jan 2018
Digital Blood Pressure Monitor-Wrist Style
K171833 · Shenzhen Combei Technology Co., Ltd. · Jan 2018
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K170467 · Microlife Intellectual Property GmbH · Aug 2017
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K171062 · Andon Health Co, Ltd. · Aug 2017
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K171282 · Andon Health Co, Ltd. · Jul 2017