Cleared Traditional

K102825 - BLOOD PRESSURE CUFF

K102825 is an FDA 510(k) clearance for BLOOD PRESSURE CUFF, manufactured by APK Technology Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K102825 · APK Technology Co., Ltd. · Cardiovascular device
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Mar 2011
Decision
154d
Days
Class 2
Risk

K102825 is an FDA 510(k) clearance for the BLOOD PRESSURE CUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by APK Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 2, 2011 after a review of 154 days - an extended review 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: 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 APK Technology Co., Ltd. devices

FDA 510(k) Submission Details - K102825

510(k) Number K102825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2010
Decision Date March 02, 2011
Days to Decision 154 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
29d slower than avg
Panel avg: 125d · This submission: 154d
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 K102825.
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
DISPOSABLE BLOOD PRESSURE CUF
K102792 · Caremate Medical Device Co., Ltd. · Jan 2011
DISPOSABLE BLOOD PRESSURE CUFF
K102823 · Wuxi Medical Instrument Factory · Jan 2011
HEINE GAMMA G7
K101892 · Heine Optotechnik GmbH & Co. KG · Aug 2010