ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
FDA 510(k) clearance K063530 · decided 2007-01-26
Clearance details
- K-number
- K063530
- Device name
- ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
- Applicant
- I-Flow Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-11-22
- Decision date
- 2007-01-26
- Days to decision
- 65 days
- Clearance type
- Special
- Product code
- MEB
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lake Forest, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery recall (Z-2860-2011) | I-Flow Corporation | 2011-07-28 |
| ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is recall (Z-1869-2008) | I-Flow Corporation | 2008-09-11 |
| On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated fo recall (Z-2133-2008) | I-Flow Corporation | 2008-09-11 |