Cleared Special

NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET

K112628 · Nipro Medical Corporation · Gastroenterology & Urology

Sep 2012

Decision

385d

Days

Class 2

Risk

About This 510(k) Submission

K112628 is an FDA 510(k) clearance for the NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II — Special Controls, product code FJK), submitted by Nipro Medical Corporation (Doral, US). The FDA issued a Cleared decision on September 28, 2012, 385 days after receiving the submission on September 9, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number	K112628 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 09, 2011
Decision Date	September 28, 2012
Days to Decision	385 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FJK — Set, Tubing, Blood, With And Without Anti-regurgitation Valve
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5820