I-Flow LLC
FDA Regulatory Profile
I-Flow LLC appears in FDA public data with 2 recalls, 42 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1444-2013, Class II) was initiated on June 1, 2012. Its most recent 510(k) clearance was granted on February 3, 2014.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 42
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1444-2013 | Class II | I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use o | June 1, 2012 |
| Z-1445-2013 | Class II | I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of ea | June 1, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K131249 | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES | February 3, 2014 |
| K063530 | ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPU | January 26, 2007 |
| K063234 | ON-Q INTRODUCERS | November 21, 2006 |
| K051401 | ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER | November 30, 2005 |
| K052117 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) | September 9, 2005 |
| K043456 | MODIFICATION TO SOAKER CATHETER | January 11, 2005 |
| K040337 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) | May 24, 2004 |
| K023883 | HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO | December 20, 2002 |
| K023827 | PARAGON INFUSION SYSTEM WITH BOLUS | December 13, 2002 |
| K023318 | I-FLOW ELASTOMERIC PUMP WITH BOLUS | October 18, 2002 |
| K022869 | SOAKER CATHETER | September 20, 2002 |
| K020862 | I-FLOW ELASTOMERIC PUMP | March 26, 2002 |
| K020660 | HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO | March 20, 2002 |
| K020251 | PARAGON INFUSION SYSTEM | February 15, 2002 |
| K994374 | SOAKER CATHETER | March 3, 2000 |
| K991543 | INTRAOP CATHETER | October 25, 1999 |
| K992072 | BOLUS ACCESSORY SET | September 15, 1999 |
| K991513 | HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO | June 21, 1999 |
| K990425 | SIDEKICK INFUSION KIT | April 23, 1999 |
| K984502 | NERVE BLOCK INFUSION KIT | March 4, 1999 |