AViTA Arm Type Blood Pressure Monitor Cuff
FDA 510(k) K250765 · Avita Corporation
510(k) numberK250765
Submission
- Device name
- AViTA Arm Type Blood Pressure Monitor Cuff
- Applicant
- Avita Corporation
New Taipei City, TW - Received
- March 13, 2025
- Decision date
- September 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXQ – Blood Pressure Cuff
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1120
- Specialty
- Cardiovascular
A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Other 510(k)s with product code DXQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254287 | Medline Reusable Blood Pressure CuffDXQ · Traditional | Medline Industries, LP | 06/22/2026SE |
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffDXQ · Traditional | Nihon Kohden Corporation | 05/06/2026SE |
| K253089 | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122…DXQ · Traditional | Shenzhen Best Electronics Co., Ltd. | 02/13/2026SE |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N)DXQ · Special | Unimed Medical Supplies, Inc. | 01/09/2026SE |
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ · Traditional | Baxter Healthcare Corporation | 12/16/2025SE |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff…DXQ · Traditional | Unimed Medical Supplies, Inc. | 07/15/2025SE |
| K242623 | Disposable Blood Pressure cuff; Reusable Blood Pressure cuffDXQ · Traditional | Shenzhen Medke Technology Co., Ltd. | 10/31/2024SE |
| K240165 | Aneroid Sphygmomanometer with Stethoscope; Aneroid SphygmomanometerDXQ · Traditional | Wenzhou Longwan Medical Device Factory | 03/20/2024SE |
| K233276 | Reusable Blood Pressure CuffDXQ · Traditional | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 12/21/2023SE |
| K232772 | Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,12…DXQ · Traditional | Shenzhen Plinma Technology Co. , Ltd. | 11/29/2023SE |
More from Shenzhen Plinma Technology Co. , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K250129 | AViTA Breast PumpHGX · Traditional | 06/11/2026SE |
| K252448 | AViTA Pulse Oximeter (SP61)DQA · Traditional | 02/27/2026SE |
| K242455 | AViTA Pulse Oximeter (SP62B)DQA · Traditional | 02/19/2025SE |
| K241852 | Nasal Aspirator (NS 13)BTA · Traditional | 12/31/2024SE |
| K242193 | Arm Type Blood Pressure Monitor (BPM82)DXN · Traditional | 10/22/2024SE |
| K223399 | AViTA Pulse OximeterDQA · Traditional | 05/20/2024SE |
| K200346 | Wrist Type Blood Pressure MonitorDXN · Traditional | 12/17/2020SE |
| K180155 | Arm Type Blood Pressure MonitorDXN · Traditional | 08/03/2018SE |
| K172427 | AViTA Radar Thermo NT16 Series IR ThermometerFLL · Traditional | 04/19/2018SE |
| K112825 | Avita Arm Type Blood Pressure MonitorDXN · Traditional | 01/18/2012SE |
Questions and answers
When was AViTA Arm Type Blood Pressure Monitor Cuff cleared by the FDA?
AViTA Arm Type Blood Pressure Monitor Cuff (K250765) received a 510(k) decision of Substantially Equivalent on September 3, 2025, 174 days after the submission was received.
What is the product code of K250765?
The FDA product code is DXQ – Blood Pressure Cuff, a Class II (moderate risk) device regulated under 21 CFR 870.1120.