I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
FDA 510(k) clearance K052117 · decided 2005-09-09
Clearance details
- K-number
- K052117
- Device name
- I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
- Applicant
- I-Flow Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-08-04
- Decision date
- 2005-09-09
- Days to decision
- 36 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 Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexic recall (Z-2111-2009) | I-Flow Corporation | 2009-09-14 |
| Easypump ST 100-1 infusion pump recall (Z-0584-06) | I-Flow Corporation | 2006-03-07 |
| Easypump L T 60-24 infusion pump recall (Z-0585-06) | I-Flow Corporation | 2006-03-07 |