Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
FDA 510(k) K160530 · Shenzhen Med-Link Electronics Tech Co., Ltd.
510(k) numberK160530
Submission
- Device name
- Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
- Applicant
- Shenzhen Med-Link Electronics Tech Co., Ltd.
Shenzhen, CN - Received
- February 25, 2016
- Decision date
- November 28, 2016
- 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 |
|---|---|---|
| K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS…FLL · Traditional | 01/08/2026SE |
| K220448 | Disposable Non-invasive EEG SensorGXY · Traditional | 01/19/2023SE |
| K220447 | Med-link Disposable ECG Cable and LeadwiresDSA · Traditional | 06/28/2022SE |
| K212752 | Med-link Pulse OximeterDQA · Traditional | 05/20/2022SE |
| K210441 | Incontinence ProbeKPI · Traditional | 09/17/2021SE |
| K202743 | Med-Link Temp-pulse OximeterDQA · Traditional | 03/01/2021SE |
| K193338 | Med-link Reusable Temperature Probes, Med-link Disposable Temperature ProbesFLL · Traditional | 08/25/2020SE |
| K181154 | Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure…DXN · Traditional | 08/02/2019SE |
| K182667 | Med-link Temperature ProbesFLL · Traditional | 06/18/2019SE |
| K173869 | Med-link Reusable Blood Pressure CuffDXQ · Traditional | 08/02/2018SE |
Questions and answers
When was Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff cleared by the FDA?
Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff (K160530) received a 510(k) decision of Substantially Equivalent on November 28, 2016, 277 days after the submission was received.
What is the product code of K160530?
The FDA product code is DXQ – Blood Pressure Cuff, a Class II (moderate risk) device regulated under 21 CFR 870.1120.