510(k) K253964

Disposable Neonatal NIBP Cuff (U1681S-C51N) by Unimed Medical Supplies, Inc. — Product Code DXQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 9, 2026
Date Received: December 11, 2025
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Blood Pressure Cuff
Device Class: Class II
Regulation Number: 870.1120
Review Panel: CV
Submission Type

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 clearances by Unimed Medical Supplies, Inc.

K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso (December 1, 2025)
K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusa (December 1, 2025)
K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Senso (November 18, 2025)
K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable (August 13, 2025)
K251045 — Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U168 (July 15, 2025)
K243086 — Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reus (February 20, 2025)
K242580 — Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip (February 6, 2025)
K222213 — Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, (December 19, 2022)
K210019 — Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model C (March 4, 2021)

Other clearances for product code DXQ

K253089 — NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-12 (February 13, 2026)
K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) (December 16, 2025)
K250765 — AViTA Arm Type Blood Pressure Monitor Cuff (September 3, 2025)
K251045 — Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U168 (July 15, 2025)
K242623 — Disposable Blood Pressure cuff; Reusable Blood Pressure cuff (October 31, 2024)
K240165 — Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer (March 20, 2024)
K233276 — Reusable Blood Pressure Cuff (December 21, 2023)
K232772 — Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,120 (November 29, 2023)
K231961 — NIBPCuff (August 30, 2023)
K230859 — Aneroid Sphygmomanometer (June 28, 2023)