Cleared Traditional

ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES

K131249 · I-Flow, LLC · General Hospital

Feb 2014

Decision

278d

Days

Class 2

Risk

About This 510(k) Submission

K131249 is an FDA 510(k) clearance for the ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES, a Pump, Infusion, Elastomeric (Class II — Special Controls, product code MEB), submitted by I-Flow, LLC (Irvine, US). The FDA issued a Cleared decision on February 3, 2014, 278 days after receiving the submission on May 1, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K131249 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2013
Decision Date	February 03, 2014
Days to Decision	278 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF