Cleared Traditional

K112544 - UNIMED BLOOD PRESSURE CUFF

K112544 is an FDA 510(k) clearance for UNIMED 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 82-day FDA review.

K112544 · Unimed Medical Supplies, Inc. · Cardiovascular device
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Nov 2011
Decision
82d
Days
Class 2
Risk

K112544 is an FDA 510(k) clearance for the UNIMED 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 November 22, 2011 after a review of 82 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 - K112544

510(k) Number K112544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2011
Decision Date November 22, 2011
Days to Decision 82 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 125d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K112544.
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 DISPOSABLE BLOOD PRESSURE CUFF
K120364 · Unimed Medical Supplies, Inc. · May 2012
ERKA. PERFECT-ANEROID
K103637 · Erka Kallmeyer Medizintechnik GmbH · Jun 2011
BLOOD PRESSURE CUFF
K102825 · APK Technology Co., Ltd. · Mar 2011
DISPOSABLE BLOOD PRESSURE CUF
K102792 · Caremate Medical Device Co., Ltd. · Jan 2011