Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B
FDA 510(k) K222994 · Shenzhen AOJ Medical Technology Co., Ltd.
510(k) numberK222994
Submission
- Device name
- Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B
- Applicant
- Shenzhen AOJ Medical Technology Co., Ltd.
Shenzhen, CN - Received
- September 28, 2022
- Decision date
- July 26, 2023
- 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 |
|---|---|---|
| K260276 | Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro…DXN · Special | 04/01/2026SE |
| K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)FLL · Traditional | 06/23/2025SE |
| K250161 | Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist…DXN · Traditional | 05/02/2025SE |
| K244000 | Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood…DXN · Traditional | 04/30/2025SE |
| K250116 | Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood…DXN · Traditional | 04/24/2025SE |
| K232989 | Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse…DQA · Traditional | 07/01/2024SE |
| K232128 | Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)FLL · Traditional | 10/14/2023SE |
| K221039 | Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F…FLL · Traditional | 12/20/2022SE |
| K222125 | Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F…DXN · Traditional | 12/01/2022SE |
| K221170 | Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106…FLL · Traditional | 10/07/2022SE |
Questions and answers
When was Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B cleared by the FDA?
Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B (K222994) received a 510(k) decision of Substantially Equivalent on July 26, 2023, 301 days after the submission was received.
What is the product code of K222994?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.