Cleared Traditional

K193259 - Aneroid sphygmomanometer with stethoscope

K193259 is the FDA 510(k) clearance for Aneroid sphygmomanometer with stethoscope by Little Doctor Electronic (Nantong)Co.,Ltd. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K193259 · Little Doctor Electronic (Nantong)Co.,Ltd · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
219d
Days
Class 2
Risk

K193259 is an FDA 510(k) clearance for the Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Little Doctor Electronic (Nantong)Co.,Ltd (Nantong, CN). The FDA issued a Cleared decision on July 2, 2020 after a review of 219 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 Little Doctor Electronic (Nantong)Co.,Ltd devices

Submission Details

510(k) Number K193259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2019
Decision Date July 02, 2020
Days to Decision 219 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
94d slower than avg
Panel avg: 125d · This submission: 219d
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 73
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K193259.
Reusable NIBP Cuff
K211747 · Shenzhen Coreray Technology Co., Ltd. · Sep 2021
Aneroid Sphygmomanometer
K203620 · Wuxi Exanovo Medical Instrument Co., Ltd. · Mar 2021
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 · Jkh USA, LLC · Jan 2021
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
Reusable NIBP Cuff
K191253 · Shenzhen Changke Connect Electronics Co., Ltd. · Sep 2019