Cleared Traditional

Disposable Blood Pressure cuff; Reusable Blood Pressure cuff

K242623 · Shenzhen Medke Technology Co., Ltd. · Cardiovascular

Oct 2024

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K242623 is an FDA 510(k) clearance for the Disposable Blood Pressure cuff; Reusable Blood Pressure cuff, a Blood Pressure Cuff (Class II — Special Controls, product code DXQ), submitted by Shenzhen Medke Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 31, 2024, 58 days after receiving the submission on September 3, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1120.

Submission Details

510(k) Number	K242623 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 03, 2024
Decision Date	October 31, 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.