Cleared Special

Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M

K152363 · Philips Medical Systems · Cardiovascular

Oct 2015

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K152363 is an FDA 510(k) clearance for the Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M, a Blood Pressure Cuff (Class II — Special Controls, product code DXQ), submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on October 27, 2015, 68 days after receiving the submission on August 20, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1120.

Submission Details

510(k) Number	K152363 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 2015
Decision Date	October 27, 2015
Days to Decision	68 days
Submission Type	Special
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.