Cleared Traditional

K251045 - Disposable Neonatal NIBP Cuff (U1682S-C51N)

Also marketed or referenced as:
Disposable Neonatal NIBP Cuff (U1683S-C51N) Disposable Neonatal NIBP Cuff (U1684S-C51N) Disposable Neonatal NIBP Cuff (U1685S-C51N)

K251045 is an FDA 510(k) clearance for Disposable Neonatal NIBP Cuff (U1682S-C51N), manufactured by Unimed Medical Supplies, Inc.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K251045 · Unimed Medical Supplies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
103d
Days
Class 2
Risk

K251045 is an FDA 510(k) clearance for the Disposable Neonatal NIBP Cuff (U1682S-C51N). Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Unimed Medical Supplies, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on July 15, 2025 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Unimed Medical Supplies, Inc. devices

FDA 510(k) Submission Details - K251045

510(k) Number K251045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 125d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXQ Device Classification - Class 2, Special Controls

Product Code DXQ Blood Pressure Cuff
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXQ Blood Pressure Cuff

All 87
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K251045.
Disposable Neonatal NIBP Cuff (U1681S-C51N)
K253964 · Unimed Medical Supplies, Inc. · Jan 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 Blood Pressure cuff
K242623 · Shenzhen Medke Technology Co., Ltd. · Oct 2024
Aneroid Sphygmomanometer with Stethoscope
K240165 · Wenzhou Longwan Medical Device Factory · Mar 2024
Reusable Blood Pressure Cuff
K233276 · Suzhou Minhua Medical Apparatus Supplies Co., Ltd. · Dec 2023