Microlife Upper Arm Automatic Digital Blood Pressure Monitor BP Progress (BP3T01-1B)
510(k) K251120
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK251120 | Date6 Aug 2025 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)
- 510(k) Number
- FDA Product Code
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor BP Progress (BP3T01-1B) is an automatic blood pressure monitor designed for upper arm use. It measures systolic and diastolic blood pressure, as well as pulse rate, in adult individuals. The device features advanced functionalities such as irregular heartbeat detection and WHO classification display, supporting clinical assessment of hypertension.
This device is supplied as a reusable, non-sterile medical instrument intended for home or clinical use. It operates without MRI compatibility restrictions and is available in a single model (BP3T01-1B). Authorised under FDA 510(k) clearance and MDR compliance, it adheres to regulatory standards for cardiovascular diagnostic devices. Storage instructions and maintenance protocols are detailed in the provided manual.
Other devices from Microlife Corporation
Questions
AI-generated answers, 18 Sep 2026
Is this blood pressure monitor designed for single-use or can it be reused over time?
This device is explicitly labeled as a reusable medical instrument, meaning it is intended for repeated use in both home and clinical settings. Since it is non-sterile, proper cleaning and maintenance as outlined in the manufacturer’s manual are required to ensure accurate readings and device longevity.
What specific features does this monitor include to assist with clinical assessment of hypertension?
The device includes irregular heartbeat detection and a WHO classification display, which help clinicians or users assess hypertension risk by categorizing blood pressure readings according to World Health Organization guidelines. These features support more informed clinical decision-making.
How is this blood pressure monitor supplied, and what should I consider when storing it?
The monitor is supplied as a single model (BP3T01-1B) in a reusable, non-sterile configuration. Storage instructions are provided in the accompanying manual, which likely include guidelines for protecting the device from moisture, extreme temperatures, and physical damage to maintain accuracy and functionality.
Does this device have any restrictions on use in environments with MRI machines?
No, the device is explicitly stated to have no MRI compatibility restrictions, meaning it can be safely used in areas where MRI scans are performed without interference or safety concerns.
What types of measurements does this blood pressure monitor provide, and who is it intended for?
The monitor measures systolic and diastolic blood pressure as well as pulse rate in adult individuals. It is designed for both home and clinical use, making it suitable for general population monitoring as well as follow-up assessments in healthcare settings.