Microlife Upper Arm Automatic Digital Blood Pressure Monitor— 510(k) K153077

Clearance details

Applicant

Microlife Intellectual Property GmbH

Product code

Code DXN

Device class

Class 2

Regulation

21 CFR 870.1130

Advisory panel

Cardiovascular

Date received

2015-10-23

Decision date

2016-02-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Widnau, CH

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• K253425 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)2026-08-13

• K230075 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K2023-06-28
• K222979 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W2023-05-19
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• K211776 — Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)2022-03-01
• K211288 — Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B2021-11-04

Death

3

Injury

169

Malfunction

1,019

Other

2

Total

1,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →