Cleared Traditional

Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer

K240165 · Wenzhou Longwan Medical Device Factory · Cardiovascular

Mar 2024

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K240165 is an FDA 510(k) clearance for the Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer, a Blood Pressure Cuff (Class II — Special Controls, product code DXQ), submitted by Wenzhou Longwan Medical Device Factory (Wenzhou, CN). The FDA issued a Cleared decision on March 20, 2024, 58 days after receiving the submission on January 22, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1120.

Submission Details

510(k) Number	K240165 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 22, 2024
Decision Date	March 20, 2024
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DXQ — Blood Pressure Cuff
Device Class	Class II — 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.