Disposable Neonatal NIBP Cuff (U1681S-C51N)
FDA 510(k) K253964 · Unimed Medical Supplies, Inc.
510(k) numberK253964
Submission
- Device name
- Disposable Neonatal NIBP Cuff (U1681S-C51N)
- Applicant
- Unimed Medical Supplies, Inc.
Shenzhen, CN - Received
- December 11, 2025
- Decision date
- January 9, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| 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 |
|---|---|---|
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes…FLL · Traditional | 06/05/2026SE |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)DQA · Special | 04/14/2026SE |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…DQA · Traditional | 12/01/2025SE |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…DQA · Traditional | 12/01/2025SE |
| K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…DQA · Traditional | 11/18/2025SE |
| K251693 | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…DQA · Traditional | 11/18/2025SE |
| K250931 | Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2…DQA · Traditional | 08/13/2025SE |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff…DXQ · Traditional | 07/15/2025SE |
| K243086 | Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable…DQA · Traditional | 02/20/2025SE |
| K242580 | Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…DQA · Traditional | 02/06/2025SE |
Questions and answers
When was Disposable Neonatal NIBP Cuff (U1681S-C51N) cleared by the FDA?
Disposable Neonatal NIBP Cuff (U1681S-C51N) (K253964) received a 510(k) decision of Substantially Equivalent on January 9, 2026, 29 days after the submission was received.
What is the product code of K253964?
The FDA product code is DXQ – Blood Pressure Cuff, a Class II (moderate risk) device regulated under 21 CFR 870.1120.