Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP
FDA 510(k) K041411 · Microlife Corp.
510(k) numberK041411
Submission
- Device name
- Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP
- Applicant
- Microlife Corp.
Great Neck, NY, US - Received
- May 27, 2004
- Decision date
- July 21, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXN – System, Measurement, Blood-Pressure, Non-Invasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1130
- Specialty
- Cardiovascular
Other 510(k)s with product code DXN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261929 | Upper Arm Blood pressure monitor (BP7155D)DXN · Special | OMRON Healthcare, Inc. | 09/10/2026SE |
| K254000 | Happy Health Blood Pressure MonitorDXN · Traditional | Happy Health, Inc. | 09/03/2026SE |
| K262658 | Automatic Digital Blood Pressure monitor (LD-526)DXN · Special | Honsun (Nantong) Co., Ltd. | 08/31/2026SE |
| K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…DXN · Traditional | JOYTECH Healthcare Co., Ltd. | 08/26/2026SE |
| K261061 | BP Go (BPP-855)DXN · Traditional | Wellvii, Inc. | 08/13/2026SE |
| K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor…DXN · Traditional | Joytech Healthcare Co. , Ltd. | 08/13/2026SE |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)DXN · Traditional | Guangzhou Daxin Health Technology Co., Ltd. | 07/23/2026SE |
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)DXN · Traditional | Microlife Corporation | 07/23/2026SE |
| K253126 | Wrist Blood Pressure Monitor (XW-05)DXN · Traditional | Shenzhen Ziqing Medical Equipment Co., Ltd. | 06/18/2026SE |
| K260693 | VicorderCS (VCS-SYS-1100)DXN · Traditional | 80 Beats Medical GmbH | 06/16/2026SE |
More from 80 Beats Medical GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)DXN · Traditional | 07/23/2026SE |
| K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B)BZH · Traditional | 06/23/2026SE |
| K251120 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress…DXN · Traditional | 08/06/2025SE |
| K122013 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Cardio+ (BP4GAPO-2M)DXN · Traditional | 05/13/2013SE |
| K080337 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2DDXN · Traditional | 05/13/2008SE |
| K073398 | Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)DXN · Special | 12/20/2007SE |
| K073397 | Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (BP A50)DXN · Special | 12/20/2007SE |
| K031024 | Microlife Electronic Peak Flow Monitor, Model PF-100BZH · Traditional | 11/14/2003SE |
| K030961 | Microlife Digital Basal Thermometer, Model MT 1921LHD · Traditional | 09/12/2003SE |
| K021305 | Microlife Wrist Watch Blood Pressure, Model BP-3BU1-5, with Optional Thermal PrinterDXN · Special | 06/28/2002SE |
Questions and answers
When was Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP cleared by the FDA?
Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP (K041411) received a 510(k) decision of Substantially Equivalent on July 21, 2004, 55 days after the submission was received.
What is the product code of K041411?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.