Cleared Special

Disposable Neonatal NIBP Cuff (U1681S-C51N)

K253964 · Unimed Medical Supplies, Inc. · Cardiovascular
Jan 2026
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K253964 is an FDA 510(k) clearance for the Disposable Neonatal NIBP Cuff (U1681S-C51N), a Blood Pressure Cuff (Class II — Special Controls, product code DXQ), submitted by Unimed Medical Supplies, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on January 9, 2026, 29 days after receiving the submission on December 11, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1120.

Submission Details

510(k) Number K253964 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2025
Decision Date January 09, 2026
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXQ — Blood Pressure Cuff
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1120
Definition 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.

Similar Devices — DXQ Blood Pressure Cuff

All 196
NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)
K253089 · Shenzhen Best Electronics Co., Ltd. · Feb 2026
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
K251745 · Baxter Healthcare Corporation · Dec 2025
AViTA Arm Type Blood Pressure Monitor Cuff
K250765 · Avita Corporation · Sep 2025
Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)
K251045 · Unimed Medical Supplies, Inc. · Jul 2025
Disposable Blood Pressure cuff; Reusable Blood Pressure cuff
K242623 · Shenzhen Medke Technology Co., Ltd. · Oct 2024
Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer
K240165 · Wenzhou Longwan Medical Device Factory · Mar 2024

More from Unimed Medical Supplies, Inc.

View all
Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)
K251691 · DQA · Dec 2025
Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)
K251696 · DQA · Dec 2025
Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75)
K251693 · DQA · Nov 2025
Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)
K251695 · DQA · Nov 2025
Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)
K250931 · DQA · Aug 2025