Cleared Traditional

K120364 - UNIMED DISPOSABLE BLOOD PRESSURE CUFF

K120364 is an FDA 510(k) clearance for UNIMED DISPOSABLE BLOOD PRESSURE CUFF, 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 88-day FDA review.

K120364 · Unimed Medical Supplies, Inc. · Cardiovascular device
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May 2012
Decision
88d
Days
Class 2
Risk

K120364 is an FDA 510(k) clearance for the UNIMED DISPOSABLE BLOOD PRESSURE CUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Unimed Medical Supplies, Inc. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on May 4, 2012 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Unimed Medical Supplies, Inc. devices

FDA 510(k) Submission Details - K120364

510(k) Number K120364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2012
Decision Date May 04, 2012
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 158
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K120364.
FLEXIPORT ECOCUFF
K122058 · Welch Allyn, Inc. · Nov 2012
SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF
K120125 · Ge Medical Systems Information Technologies, Inc. · Oct 2012
BLOOD PRESSURE MONITOR WITH STETHOSCOPE
K122259 · Hangzhou Reli-On Co., Ltd. · Sep 2012
UNIMED BLOOD PRESSURE CUFF
K112544 · Unimed Medical Supplies, Inc. · Nov 2011
ERKA. PERFECT-ANEROID
K103637 · Erka Kallmeyer Medizintechnik GmbH · Jun 2011
BLOOD PRESSURE CUFF
K102825 · APK Technology Co., Ltd. · Mar 2011