Cleared Traditional

K230859 - Aneroid Sphygmomanometer

K230859 is an FDA 510(k) clearance for Aneroid Sphygmomanometer, manufactured by Wenzhou Kangshun Medical Devices Co.,Ltd. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K230859 · Wenzhou Kangshun Medical Devices Co.,Ltd · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
91d
Days
Class 2
Risk

K230859 is an FDA 510(k) clearance for the Aneroid Sphygmomanometer. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Wenzhou Kangshun Medical Devices Co.,Ltd (Wenzhou City, CN). The FDA issued a Cleared decision on June 28, 2023 after a review of 91 days - within the typical 510(k) review window.

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 Wenzhou Kangshun Medical Devices Co.,Ltd devices

FDA 510(k) Submission Details - K230859

510(k) Number K230859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2023
Decision Date June 28, 2023
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
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 K230859.
Reusable Blood Pressure Cuff
K233276 · Suzhou Minhua Medical Apparatus Supplies Co., Ltd. · Dec 2023
Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2)
K232772 · Shenzhen Plinma Technology Co. , Ltd. · Nov 2023
NIBPCuff
K231961 · Shenzhen Sino-K Medical Technology Co.,Ltd · Aug 2023
ONE-CUF
K230145 · Ge Medical Systems Information Technologies, Inc. · Mar 2023
Aneroid Sphygmomanometer
K222652 · Cardicare Company, Ltd. · Nov 2022
Disposable Blood Pressure Cuff
K222420 · Wenzhou Xikang Medical Instruments Co., Ltd. · Nov 2022