Cleared Traditional

K261082 - Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)

K261082 is an FDA 510(k) clearance for Microlife Wrist Blood Pressure Monitor, manufactured by Microlife Corporation. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K261082 · Microlife Corporation · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2026
Decision
113d
Days
Class 2
Risk

K261082 is an FDA 510(k) clearance for the Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G). Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Microlife Corporation (Taipei, CN). The FDA issued a Cleared decision on July 23, 2026 after a review of 113 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 Corporation devices

FDA 510(k) Submission Details - K261082

510(k) Number K261082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2026
Decision Date July 23, 2026
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
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.
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 840
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K261082.
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K261394 · Joytech Healthcare Co. , Ltd. · Aug 2026
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