Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)— 510(k) K261082
Substantially EquivalentMicrolife Corporation
FDA 510(k) clearance K261082 for Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G), Substantially Equivalent on 2026-07-23. Applicant: Microlife Corporation. Device class: 2.
Summary
Microlife's Wrist Blood Pressure Monitor (Model BPHJG5-G) is filed under DXN, non-invasive blood pressure measurement systems. The record gives the model number but no specs.
Class II, 21 CFR 870.1130. Cardiovascular is both the classification panel and the review panel, and it was a Traditional 510(k).
Microlife filed from Taipei. Review took 113 calendar days (April 1 to July 23, 2026).
Clearance details
- Applicant
- Microlife Corporation
- Product code
- Product code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taipei, CN
Recent devices under product code DXN
view all- K260670 — YUWELL® Electronic Blood Pressure Monitor
- K260470 — Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)
- K261929 — Upper Arm Blood pressure monitor (BP7155D)
- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
More clearances from Microlife Corporation
view allAdverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.