510(k) K251120

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) by Microlife Corporation — Product Code DXN

K251120 is an FDA 510(k) premarket notification submitted by Microlife Corporation for the device "Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)". The FDA issued a decision of Substantially Equivalent on Aug 6, 2025. 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 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 6, 2025
Date Received
Apr 11, 2025
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
510(k)

Source: FDA 510(k) database entry for K251120. Report a data issue: hello@regdatalab.com.