Healthcheck Auto Inflate Digital BP Monitor BP-2
FDA 510(k) K850070 · Healthcheck Corp.
510(k) numberK850070
Submission
- Device name
- Healthcheck Auto Inflate Digital BP Monitor BP-2
- Applicant
- Healthcheck Corp.
Cheshire, CT, US - Received
- January 4, 1985
- Decision date
- January 22, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K884489 | C&T Pregnancy Test KitLCX · Traditional | 03/08/1989SE |
| K874818 | TenstarGZJ · Traditional | 09/28/1988SE |
| K881003 | Digital Blood Pressure Monitor Model CX-1DXN · Traditional | 05/18/1988SE |
| K863181 | Healthcheck Therm-StripFQZ · Traditional | 09/11/1986SE |
| K861946 | PTK Plus. Home Pregnancy TestLCX · Traditional | 06/16/1986SE |
| K860287 | Pulsonic Digital Blood Pressure Monitor Model BP-3DXN · Traditional | 04/28/1986SE |
| K851379 | Healthcheck Digital Thermometer Model 1 TH-2FLL · Traditional | 04/12/1985SE |
| K844281 | PTK Healthcheck Pregnancy Test KitLCX · Traditional | 12/10/1984SE |
Questions and answers
When was Healthcheck Auto Inflate Digital BP Monitor BP-2 cleared by the FDA?
Healthcheck Auto Inflate Digital BP Monitor BP-2 (K850070) received a 510(k) decision of Substantially Equivalent on January 22, 1985, 18 days after the submission was received.
What is the product code of K850070?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.