Cleared Traditional

K063863 - ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER

K063863 is an FDA 510(k) clearance for ADVANTAGE CUFF, manufactured by Advantage Medical Cables, 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.

K063863 · Advantage Medical Cables, Inc. · Cardiovascular device
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Mar 2007
Decision
82d
Days
Class 2
Risk

K063863 is an FDA 510(k) clearance for the ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Advantage Medical Cables, Inc. (Coral Springs, US). The FDA issued a Cleared decision on March 20, 2007 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 Advantage Medical Cables, Inc. devices

FDA 510(k) Submission Details - K063863

510(k) Number K063863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2006
Decision Date March 20, 2007
Days to Decision 82 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
43d faster than avg
Panel avg: 125d · This submission: 82d
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 143
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K063863.
DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES
K080366 · Zefon Intl. · Jun 2008
MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF
K071244 · Medline Industries, Inc. · Mar 2008
WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
K070060 · Welch Allyn, Inc. · Dec 2007
TYTAN BLOOD PRESSURE CUFF
K062238 · Tytan Medical Corp. · Sep 2006
SURGI-CUF REUSABLE, RS SERIES
K061962 · Ethox International · Jul 2006
AS101, BLOOD PRESSURE CUFF
K060871 · Wenzhou Longwan Medical Instrument Company · Jun 2006