510(k) K261082

Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) by Microlife Corporation — Product Code DXN

K261082 is an FDA 510(k) premarket notification submitted by Microlife Corporation for the device "Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)". The FDA issued a decision of Substantially Equivalent on July 23, 2026. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Microlife Corporation has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2026
Date Received
April 1, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type