K221319 is an FDA 510(k) clearance for the BD Alaris™ Pump Epidural Infusion Set. This device is classified as a Administrations Sets With Neuraxial Connectors (Class II - Special Controls, product code PWH).
Submitted by Care Fusion (San Diego, US). The FDA issued a Cleared decision on July 21, 2023, 441 days after receiving the submission on May 6, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440. The Connector For Neuraxial Applications Is Intended To Facilitate Ansi/aami/iso 80369-6:2016 Compliant Neuraxial Specific Connections..
| 510(k) Number | K221319 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2022 |
| Decision Date | July 21, 2023 |
| Days to Decision | 441 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PWH — Administrations Sets With Neuraxial Connectors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |
| Definition | The Connector For Neuraxial Applications Is Intended To Facilitate Ansi/aami/iso 80369-6:2016 Compliant Neuraxial Specific Connections. |