Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
FDA 510(k) K192500 · Honsun (Nantong) Co., Ltd.
510(k) numberK192500
Submission
- Device name
- Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
- Applicant
- Honsun (Nantong) Co., Ltd.
Nantong, CN - Received
- September 12, 2019
- Decision date
- April 6, 2020
- 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 |
| K250765 | AViTA Arm Type Blood Pressure Monitor CuffDXQ · Traditional | Avita Corporation | 09/03/2025SE |
| 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 |
More from Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K262658 | Automatic Digital Blood Pressure monitor (LD-526)DXN · Special | 08/31/2026SE |
| K252399 | Portable Oxygen ConcentratorCAW · Traditional | 06/17/2026SE |
| K260260 | Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521…DXN · Special | 04/28/2026SE |
| K251795 | Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)DXN · Special | 10/09/2025SE |
| K211629 | Infrared forehead thermometer LD-FT-100BFLL · Traditional | 12/08/2021SE |
| K170866 | Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579DXN · Special | 02/21/2018SE |
| K170466 | Automatic Blood Pressure Monitor Model LD-518 & LD-537DXN · Traditional | 10/27/2017SE |
| K170454 | Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533UDXN · Traditional | 10/25/2017SE |
| K132627 | Automatic Digital Blood Pressure MonitorDXN · Special | 10/23/2013SE |
| K130925 | Automatic Blood Pressure MonitorDXN · Traditional | 09/12/2013SE |
Questions and answers
When was Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer cleared by the FDA?
Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer (K192500) received a 510(k) decision of Substantially Equivalent on April 6, 2020, 207 days after the submission was received.
What is the product code of K192500?
The FDA product code is DXQ – Blood Pressure Cuff, a Class II (moderate risk) device regulated under 21 CFR 870.1120.