Cleared Traditional

K043286 - ANEROID SPHYGMOMANOMETER, MODEL BK2002

K043286 is an FDA 510(k) clearance for ANEROID SPHYGMOMANOMETER, manufactured by Wenzhou Bokang Instrument Co.,Ltd. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K043286 · Wenzhou Bokang Instrument Co.,Ltd · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
48d
Days
Class 2
Risk

K043286 is an FDA 510(k) clearance for the ANEROID SPHYGMOMANOMETER, MODEL BK2002. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Wenzhou Bokang Instrument Co.,Ltd (Metairie, US). The FDA issued a Cleared decision on January 13, 2005 after a review of 48 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.

FDA 510(k) Submission Details - K043286

510(k) Number K043286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2004
Decision Date January 13, 2005
Days to Decision 48 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
77d faster than avg
Panel avg: 125d · This submission: 48d
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

Center For Measurement Standards of Industrial
TZU-WEI LI

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 193
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K043286.
TRICOT BLOOD PRESSURE CUFF
K051539 · Ya Horng Electronic Co., Ltd. · Aug 2005
ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A
K051021 · Shanghai Lord International Trade Co., Ltd. · Jun 2005
MULTIPLE, MODEL KTJ-50
K043444 · Golden Horse Medical Equipment (Wuxi) Co. , Ltd. · Feb 2005
POLYURETHANE BLOOD PRESSURE CUFFS
K041689 · D. E. Hokanson, Inc. · Aug 2004
BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193
K032568 · Med Textile, LLC · Apr 2004
ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS
K040286 · Ethox Corp. · Mar 2004
K043286 · ANEROID SPHYGMOMANOMETER, MODEL BK2002
Download PDF FDA Summary Wenzhou Bokang Instru…