Cleared Abbreviated

K080366 - DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES

K080366 is an FDA 510(k) clearance for DURACHECK BLOOD PRESSURE CUFF, manufactured by Zefon Intl.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Abbreviated 510(k) pathway after a 118-day FDA review.

K080366 · Zefon Intl. · Cardiovascular device
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Jun 2008
Decision
118d
Days
Class 2
Risk

K080366 is an FDA 510(k) clearance for the DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Zefon Intl. (Ocala, US). The FDA issued a Cleared decision on June 9, 2008 after a review of 118 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Zefon Intl. devices

FDA 510(k) Submission Details - K080366

510(k) Number K080366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2008
Decision Date June 09, 2008
Days to Decision 118 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 125d · This submission: 118d
Pathway characteristics
Standards-based clearance path.

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 K080366.
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A
K082542 · Cardicare Company, Ltd. · Sep 2008
TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX
K080189 · Trimline Medical Products Corp. · Aug 2008
ANEROID SPHYGMOMANOMETER, MODEL KT-A01
K081951 · Wenzhou Kindcare Import & Export Co., Ltd. · Aug 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
ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER
K063863 · Advantage Medical Cables, Inc. · Mar 2007