I-Flow LLC

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
42
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1444-2013Class III-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use oJune 1, 2012
Z-1445-2013Class III-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of eaJune 1, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K131249ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIESFebruary 3, 2014
K063530ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUJanuary 26, 2007
K063234ON-Q INTRODUCERSNovember 21, 2006
K051401ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETERNovember 30, 2005
K052117I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)September 9, 2005
K043456MODIFICATION TO SOAKER CATHETERJanuary 11, 2005
K040337I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)May 24, 2004
K023883HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVODecember 20, 2002
K023827PARAGON INFUSION SYSTEM WITH BOLUSDecember 13, 2002
K023318I-FLOW ELASTOMERIC PUMP WITH BOLUSOctober 18, 2002
K022869SOAKER CATHETERSeptember 20, 2002
K020862I-FLOW ELASTOMERIC PUMPMarch 26, 2002
K020660HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVOMarch 20, 2002
K020251PARAGON INFUSION SYSTEMFebruary 15, 2002
K994374SOAKER CATHETERMarch 3, 2000
K991543INTRAOP CATHETEROctober 25, 1999
K992072BOLUS ACCESSORY SETSeptember 15, 1999
K991513HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVOJune 21, 1999
K990425SIDEKICK INFUSION KITApril 23, 1999
K984502NERVE BLOCK INFUSION KITMarch 4, 1999