BD Alaris™ Pump Epidural Infusion Set
FDA 510(k) clearance K221319 · decided 2023-07-21
Clearance details
- K-number
- K221319
- Device name
- BD Alaris™ Pump Epidural Infusion Set
- Applicant
- Care Fusion
- Decision
- Substantially Equivalent
- Date received
- 2022-05-06
- Decision date
- 2023-07-21
- Days to decision
- 441 days
- Clearance type
- Traditional
- Product code
- PWH
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PCEA Syringe Set (K211649) | Baxter Healthcare Corporation | 2021-11-23 |
| CADD Yellow High Volume Administration Set with NRFit connector (K172592) | Smiths Medical Asd, Inc. | 2018-05-17 |
| CADD® Infusion Disposables Portfolio with NRFit™ connectors (K162219) | Smiths Medical Asd, Inc. | 2017-07-20 |
Recalls involving this device
No recalls on record reference this clearance.