Propaq 102, 104 and 106
FDA 510(k) K910772 · Protocol Systems, Inc.
510(k) numberK910772
Submission
- Device name
- Propaq 102, 104 and 106
- Applicant
- Protocol Systems, Inc.
Beaverton, OR, US - Received
- February 22, 1991
- Decision date
- April 12, 1991
- 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 |
|---|---|---|
| K002725 | Micropaq, Models 402 and 404DRT · Traditional | 11/21/2000SE |
| K972121 | Acuity Central StationMLD · Traditional | 11/07/1997SE |
| K951246 | Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography OptionsFLS · Traditional | 02/02/1996ST |
| K945071 | Propaq 200 MonitorDRT · Traditional | 05/10/1995SE |
| K935846 | Model Acuity Central StationDSI · Traditional | 12/05/1994SE |
| K934711 | Propaq ECG Telemetry OptionDRG · Traditional | 09/01/1994SE |
| K921497 | Propaq Monitors, ModificationCCK · Traditional | 03/23/1993SE |
| K914838 | Propaq 102,104,106,102EL,104EL,&106ELMHX · Traditional | 01/10/1992SE |
| K913193 | Model 100 Central StationDQK · Traditional | 10/16/1991SE |
| K910882 | Propaq 102EL, 104EL and 106ELDRT · Traditional | 05/08/1991SE |
Questions and answers
When was Propaq 102, 104 and 106 cleared by the FDA?
Propaq 102, 104 and 106 (K910772) received a 510(k) decision of Substantially Equivalent on April 12, 1991, 49 days after the submission was received.
What is the product code of K910772?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.