Cleared Traditional

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. · Cardiovascular
Jul 2025
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K251045 is an FDA 510(k) clearance for the Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-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 July 15, 2025, 103 days after receiving the submission on April 3, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1120.

Submission Details

510(k) Number K251045 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2025
Decision Date July 15, 2025
Days to Decision 103 days
Submission Type Traditional
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

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