Cleared Traditional

K202729 - Microlife Upper Arm Automatic Digital B...

K202729 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 202-day FDA review.

K202729 · Microlife Intellectual Property GmbH · Cardiovascular device
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Apr 2021
Decision
202d
Days
Class 2
Risk

K202729 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 (Widnau, CH). The FDA issued a Cleared decision on April 8, 2021 after a review of 202 days - an extended review 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: 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 devices

FDA 510(k) Submission Details - K202729

510(k) Number K202729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2020
Decision Date April 08, 2021
Days to Decision 202 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
77d slower than avg
Panel avg: 125d · This submission: 202d
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 Consutants, Inc.
Vaibhav Arvind Rajal

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
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