Cleared Traditional

Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D (K203652) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203652 · Jkh USA, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 59
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