Cleared Abbreviated

K010686 - KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C

K010686 is an FDA 510(k) clearance for KTJ-20C BLOOD PRESSURE CUFF, manufactured by Golden Horse Medical Equipment (Wuxi) Co. , Ltd.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Abbreviated 510(k) pathway after a 13-day FDA review.

K010686 · Golden Horse Medical Equipment (Wuxi) Co. , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
13d
Days
Class 2
Risk

K010686 is an FDA 510(k) clearance for the KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Golden Horse Medical Equipment (Wuxi) Co. , Ltd. (Ridgewood, US). The FDA issued a Cleared decision on March 21, 2001 after a review of 13 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 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.

FDA 510(k) Submission Details - K010686

510(k) Number K010686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2001
Decision Date March 21, 2001
Days to Decision 13 days
Submission Type Abbreviated
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
112d faster than avg
Panel avg: 125d · This submission: 13d
Pathway characteristics
Standards-based clearance path. 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

Entela, Inc.
N.E. DEVINE, JR.

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 198
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K010686.
GSIBP BLOOD PRESSURE CUFF
K012553 · Globalshop, Inc. · Aug 2001
ABN ANEROID SPHYGMOMANOMETER
K012444 · Pt. Sugih Instrumendo Abadi · Aug 2001
BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110
K012194 · Nihon Seimitsu Sokki Co., Ltd. · Jul 2001
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE
K003415 · Wang & Li, Inc. · Jan 2001
RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS
K002954 · Rudolf Riester GmbH & Co. KG · Dec 2000
EMPIRE N BLOOD PRESSURE MANOMETERS
K002955 · Rudolf Riester GmbH & Co. KG · Dec 2000
K010686 · KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C
Download PDF FDA Summary Golden Horse Medical …