Company ยท US
I-Flow Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2014. Name variants (Inc, Corp, punctuation) are merged.
42510(k) clearances (0 in 12 months)
18recalls (0 in 12 months)
17recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 3, 2014 | K131249 | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES I-Flow, LLC | MEB |
| Jan 26, 2007 | K063530 | ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP I-Flow Corp. | MEB |
| Nov 21, 2006 | K063234 | ON-Q INTRODUCERS I-Flow Corp. | BSO |
| Nov 30, 2005 | K051401 | ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER I-Flow Corp. | BSO |
| Sep 9, 2005 | K052117 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) I-Flow Corp. | MEB |
| Jan 11, 2005 | K043456 | MODIFICATION TO SOAKER CATHETER I-Flow Corp. | BSO |
| May 24, 2004 | K040337 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) I-Flow Corp. | MEB |
| Dec 20, 2002 | K023883 | HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO I-Flow Corp. | MEB |
| Dec 13, 2002 | K023827 | PARAGON INFUSION SYSTEM WITH BOLUS I-Flow Corp. | FRN |
| Oct 18, 2002 | K023318 | I-FLOW ELASTOMERIC PUMP WITH BOLUS I-Flow Corp. | MEB |
| Sep 20, 2002 | K022869 | SOAKER CATHETER I-Flow Corp. | FRN |
| Mar 26, 2002 | K020862 | I-FLOW ELASTOMERIC PUMP I-Flow Corp. | MEB |
| Mar 20, 2002 | K020660 | HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO I-Flow Corp. | MEB |
| Feb 15, 2002 | K020251 | PARAGON INFUSION SYSTEM I-Flow Corp. | FRN |
| Mar 3, 2000 | K994374 | SOAKER CATHETER I-Flow Corp. | FRN |
| Oct 25, 1999 | K991543 | INTRAOP CATHETER I-Flow Corp. | MEB |
| Sep 15, 1999 | K992072 | BOLUS ACCESSORY SET I-Flow Corp. | FPA |
| Jun 21, 1999 | K991513 | HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO I-Flow Corp. | FPA |
| Apr 23, 1999 | K990425 | SIDEKICK INFUSION KIT I-Flow Corp. | FRN |
| Mar 4, 1999 | K984502 | NERVE BLOCK INFUSION KIT I-Flow Corp. | MEB |
| Feb 22, 1999 | K984441 | KVO CHECK VALVE ACCESSORY, MODEL EV-0001 I-Flow Corp. | FPA |
| Feb 9, 1999 | K984638 | PARAGON BOLUS ACCESSORY SET I-Flow Corp. | FPA |
| Feb 9, 1999 | K984146 | PARAGON INFUSION I-Flow Corp. | FPA |
| Feb 9, 1999 | K984063 | PARAGON BASAL/BOLUS ADMINISTRATION SET I-Flow Corp. | FPA |
| Nov 18, 1998 | K982946 | PAINBUSTER INFUSION KIT I-Flow Corp. | MEB |
| May 28, 1998 | K980558 | PAINBUSTER INFUSION SYSTEM I-Flow Corp. | MEB |
| Aug 15, 1997 | K972173 | MEDI-SIS SYRINGE INFUSION SYSTEM I-Flow Corp. | MEB |
| Feb 8, 1996 | K955727 | BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET I-Flow Corp. | MEB |
| Sep 29, 1995 | K954059 | TITAN 20 CC DRIVER I-Flow Corp. | MEB |
| Sep 28, 1995 | K953028 | TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET I-Flow Corp. | MEB |
| Aug 18, 1995 | K952760 | FIXED FLOW RATE GRAVITY ADMINISTRATION SETS I-Flow Corp. | FPA |
| Jul 18, 1995 | K941418 | INFUSION PUMP I-Flow Corp. | MEB |
| Feb 3, 1995 | K940657 | IV BAG PUMP I-Flow Corp. | FPA |
| Jan 20, 1995 | K935811 | BOLUS DISPENSER I-Flow Corp. | FPA |
| Mar 29, 1994 | K924527 | VIVUS 5000 INFUSION SYSTEM I-Flow Corp. | FRN |
| May 13, 1993 | K923875 | SIDEKICK 50 PLUS AND SIDEKICK 100 PLUS I-Flow Corp. | FRN |
| Jun 15, 1992 | K915646 | VIVUS 50 AND VIVUS 100 PERSONAL INFUSER I-Flow Corp. | FRN |
| Dec 13, 1991 | K913907 | VIVUS PS (PROGRAMMING SOFTWARE) I-Flow Corp. | FRN |
| Oct 1, 1990 | K904048 | MULTI DRUG INFUSION SYSTEM I-Flow Corp. | FRN |
| Sep 28, 1990 | K901978 | MULTI-DRUG INFUSION SYSTEM I-Flow Corp. | FRN |
| Aug 28, 1989 | K892210 | MULTI-DRUG(TM) INFUSION SYSTEM I-Flow Corp. | FRN |
| Oct 14, 1988 | K883003 | MULTI-DRUG INFUSION SYSTEM I-Flow Corp. | FRN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2013 | I-Flow LLC I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T
The intended use of each component in the finished final trays is consistent with the intended use of the component stated i Terminated |
BSO | K904440 |
| Jun 3, 2013 | I-Flow LLC I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T
The intended use of each component in the finished final trays is consistent with the intended use of the component stat Terminated |
BSO | K904440 |
| Aug 28, 2012 | I-Flow Corporation ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1 Terminated |
MEB | K023318 |
| Jul 28, 2011 | I-Flow Corporation I-Flow ON-Q with Select-A-Flow Pumps,
Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for preoperative, periope Terminated |
MEB | K063530 |
| Sep 24, 2009 | I-Flow Corporation B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 60-24, 60 ml x 2 ml/hr Terminated |
FMF | K071459 |
| Sep 24, 2009 | I-Flow Corporation B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 100-48, 100 ml x 2 ml/hr
Used to provide an optional filling device for the Easypump. Terminated |
FMF | K071459 |
| Sep 14, 2009 | I-Flow Corporation I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico.
The Easypump LT is indicated for continuous and/or intermittent infusion of medication for general infusi Terminated |
MEB | K052117 |
| Sep 11, 2008 | I-Flow Corporation On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around Terminated |
MEB | K063530 |
| Sep 11, 2008 | I-Flow Corporation ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) Terminated |
MEB | K063530 |
| Oct 6, 2007 | I-Flow Corporation ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, I-Flow Corporation, Lake Forest, CA 92630 U.S.A. Terminated |
MED | K932740 |
| Jan 18, 2007 | I-Flow Corporation I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742 Terminated |
MEB | K932740 |
| Mar 7, 2006 | I-Flow Corporation Easypump L T 60-24 infusion pump Terminated |
MEB | K052117 K932740 |
| Mar 7, 2006 | I-Flow Corporation Easypump ST 100-1 infusion pump Terminated |
MEB | K052117 K932740 |
| Jan 9, 2004 | I-Flow Corporation Easypump LT 100-200
Elastomeric Infusion Pump (100 ml x 0.5 ml/hr)
Part number: 5001120 Terminated |
MEB | None listed |
| Jan 9, 2004 | I-Flow Corporation Eclipse Infusion Pump, 250 ml X 250 ml per hour)
Part 5001247 Terminated |
MEB | K020862 |
| Apr 18, 2003 | I-Flow Corporation Easypump LT 60-24
Easypump Infusion Pump (60 ml x 2 ml/hr) Terminated |
K991513 | |
| Apr 3, 2003 | I-Flow Corporation Paragon Administration Set (100 ml x 0.5 ml/hr)
Part Number 5000936 Terminated |
FRN | K923875 |
| Mar 27, 2003 | I-Flow Corporation Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr)
Model E100500
Part No. 5001065 Terminated |
MEB | K932740 |