Cleared Special

K253964 - Disposable Neonatal NIBP Cuff (U1681S-C51N) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K253964 · Unimed Medical Supplies, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 2026
Decision
29d
Days
Class 2
Risk

K253964 is an FDA 510(k) clearance for the Disposable Neonatal NIBP Cuff (U1681S-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 January 9, 2026 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Unimed Medical Supplies, Inc. devices

Submission Details

510(k) Number K253964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 196
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K253964.
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)
K251045 · Unimed Medical Supplies, Inc. · Jul 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