Cleared Traditional

K203652 - Blood Pressure Cuff

K203652 is an FDA 510(k) clearance for Blood Pressure Cuff, manufactured by Jkh USA, LLC. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K203652 · Jkh USA, LLC · Cardiovascular device
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Jan 2021
Decision
23d
Days
Class 2
Risk

K203652 is an FDA 510(k) clearance for the Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pre.... Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Jkh USA, LLC (Walnut, US). The FDA issued a Cleared decision on January 6, 2021 after a review of 23 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.

View all Jkh USA, LLC devices

FDA 510(k) Submission Details - K203652

510(k) Number K203652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2020
Decision Date January 06, 2021
Days to Decision 23 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
102d faster than avg
Panel avg: 125d · This submission: 23d
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 87
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K203652.
Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope
K211084 · Shanghai Caremate Medical Device Co., Ltd. · Oct 2021
Reusable NIBP Cuff
K211747 · Shenzhen Coreray Technology Co., Ltd. · Sep 2021
Aneroid Sphygmomanometer
K203620 · Wuxi Exanovo Medical Instrument Co., Ltd. · Mar 2021
Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
K193259 · Little Doctor Electronic (Nantong)Co.,Ltd · Jul 2020
Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
K192500 · Honsun (Nantong) Co., Ltd. · Apr 2020
Disposable NIBP Cuff
K193629 · Shenzhen Changke Connect Electronics Co., Ltd. · Mar 2020