I-Flow Corp.
Medical device manufacturer in Irvine, CA.
42510(k) clearances
0PMA approvals
11recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K131249 | On-Q Painbuster, On-Q C-Bloc, Homepump Eclipse, Homepump C-SeriesMEB · Traditional | 02/03/2014SE |
| K063530 | On-Q, Painbuster, C-Bloc, Select-A-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step…MEB · Special | 01/26/2007SE |
| K063234 | On-Q IntroducersBSO · Abbreviated | 11/21/2006SE |
| K051401 | On-Q Catheter, On-Antimicrobial Catheter, Soaker Catheter, I-Flow CatheterBSO · Traditional | 11/30/2005SE |
| K052117 | I-Flow Elastomeric Pump (On-Q, Painbuster, C-Block, Homepump, Easypump)MEB · Special | 09/09/2005SE |
| K043456 | Modification to Soaker CatheterBSO · Special | 01/11/2005SE |
| K040337 | I-Flow Elastomeric Pump (On-Q, Painbuster, C-Bloc, Homepump)MEB · Traditional | 05/24/2004SE |
| K023883 | Homepump, Eclipse, C-Series, Painbuster, C-Bloc, On-Q, Easypump, KvoMEB · Special | 12/20/2002SE |
| K023827 | Paragon Infusion System with BolusFRN · Special | 12/13/2002SE |
| K023318 | I-Flow Elastomeric Pump with BolusMEB · Special | 10/18/2002SE |
| K022869 | Soaker CatheterFRN · Special | 09/20/2002SE |
| K020862 | I-Flow Elastomeric PumpMEB · Special | 03/26/2002SE |
| K020660 | Homepump, Eclipse, C-Series, Painbuster, C-Bloc, On-Q, Easypump, One Step KvoMEB · Special | 03/20/2002SE |
| K020251 | Paragon Infusion SystemFRN · Special | 02/15/2002SE |
| K994374 | Soaker CatheterFRN · Traditional | 03/03/2000SE |
| K991543 | Intraop CatheterMEB · Traditional | 10/25/1999SE |
| K992072 | Bolus Accessory SetFPA · Traditional | 09/15/1999SE |
| K991513 | Homepump C-Series and Homepump C-Series One-Step KvoFPA · Traditional | 06/21/1999SE |
| K990425 | Sidekick Infusion KitFRN · Traditional | 04/23/1999SE |
| K984502 | Nerve Block Infusion KitMEB · Traditional | 03/04/1999SE |
| K984441 | Kvo Check Valve Accessory, Model EV-0001FPA · Traditional | 02/22/1999SE |
| K984638 | Paragon Bolus Accessory SetFPA · Traditional | 02/09/1999SE |
| K984146 | Paragon InfusionFPA · Traditional | 02/09/1999SE |
| K984063 | Paragon Basal/Bolus Administration SetFPA · Traditional | 02/09/1999SE |
| K982946 | Painbuster Infusion KitMEB · Traditional | 11/18/1998SE |
| K980558 | Painbuster Infusion SystemMEB · Traditional | 05/28/1998SE |
| K972173 | Medi-Sis Syringe Infusion SystemMEB · Traditional | 08/15/1997SE |
| K955727 | Band-It 20CC Driver/ 15 Min 20CC Administration SetMEB · Traditional | 02/08/1996SE |
| K954059 | Titan 20 CC DriverMEB · Traditional | 09/29/1995SE |
| K953028 | Titan Driver 60CC, 30 Minute Administration SetMEB · Traditional | 09/28/1995SE |
| K952760 | Fixed Flow Rate Gravity Administration SetsFPA · Traditional | 08/18/1995SE |
| K941418 | Infusion PumpMEB · Traditional | 07/18/1995SE |
| K940657 | IV Bag PumpFPA · Traditional | 02/03/1995SE |
| K935811 | Bolus DispenserFPA · Traditional | 01/20/1995SE |
| K924527 | Vivus 5000 Infusion SystemFRN · Traditional | 03/29/1994SE |
| K923875 | Sidekick 50 Plus and Sidekick 100 PlusFRN · Traditional | 05/13/1993SE |
| K915646 | Vivus 50 and Vivus 100 Personal InfuserFRN · Traditional | 06/15/1992SE |
| K913907 | Vivus PS (Programming Software)FRN · Traditional | 12/13/1991SE |
| K904048 | Multi Drug Infusion SystemFRN · Traditional | 10/01/1990SE |
| K901978 | Multi-Drug Infusion SystemFRN · Traditional | 09/28/1990SE |
| K892210 | Multi-Drug(Tm) Infusion SystemFRN · Traditional | 08/28/1989SE |
| K883003 | Multi-Drug Infusion SystemFRN · Traditional | 10/14/1988SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1445-2013 Class II | I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended…I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray… | 06/01/2012Terminated |
| Z-1444-2013 Class II | I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The…I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray… | 06/01/2012Terminated |
| Z-2253-2012 Class I | ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select…It was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not lock in the… | 05/08/2012Terminated |
| Z-2860-2011 | I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent…The recall was initiated because I Flow became aware that a small percentage of ON-Q Pump with Select A Flow… | 04/15/2011Terminated |
| Z-2250-2009 | B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 60-24, 60 ml x 2 ml/hrI-Flow identified a B. Braun syringe package that had a tear/hole in the paper portion of the primary… | 08/01/2008Terminated |
| Z-2249-2009 | B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 100-48, 100 ml x 2…I-Flow identified a B. Braun syringe package that had a tear/hole in the paper portion of the primary package. | 08/01/2008Terminated |
| Z-2133-2008 | On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated…Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label. | 02/14/2008Terminated |
| Z-1869-2008 | ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump…The ON-Q PainBuster, REF PS6504 (lot number 772166), box may contain the wrong product, ON-Q PainBuster, REF… | 02/12/2008Terminated |
| Z-2111-2009 | I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in…I-Flow Corporation received two complaints involving Easypump LT 60-24 (Lot 612996) containing a 100 ml x 2… | 02/11/2008Terminated |
| Z-0057-2008 | ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model…Misassembly: The ON-Q PainBuster PMB01 package may contain a Soaker catheter instead of a Non-Soaker… | 03/27/2007Terminated |
| Z-0358-2007 | I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742The pump flow rate labeling may not match the package labeling. The label on filter may not match the label… | 11/29/2006Terminated |