Cleared Traditional

K102823 - DISPOSABLE BLOOD PRESSURE CUFF

K102823 is an FDA 510(k) clearance for DISPOSABLE BLOOD PRESSURE CUFF, manufactured by Wuxi Medical Instrument Factory. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K102823 · Wuxi Medical Instrument Factory · Cardiovascular device
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Jan 2011
Decision
100d
Days
Class 2
Risk

K102823 is an FDA 510(k) clearance for the DISPOSABLE BLOOD PRESSURE CUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Wuxi Medical Instrument Factory (Shanghai, CN). The FDA issued a Cleared decision on January 7, 2011 after a review of 100 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Wuxi Medical Instrument Factory devices

FDA 510(k) Submission Details - K102823

510(k) Number K102823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2010
Decision Date January 07, 2011
Days to Decision 100 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 125d · This submission: 100d
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 144
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K102823.
UNIMED DISPOSABLE BLOOD PRESSURE CUFF
K120364 · Unimed Medical Supplies, Inc. · May 2012
UNIMED BLOOD PRESSURE CUFF
K112544 · Unimed Medical Supplies, Inc. · Nov 2011
ERKA. PERFECT-ANEROID
K103637 · Erka Kallmeyer Medizintechnik GmbH · Jun 2011
VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES
K082630 · Zefon Intl. · Dec 2008
DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100
K080854 · Suntech Medical, Inc. · Oct 2008
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A
K082542 · Cardicare Company, Ltd. · Sep 2008