Cleared Traditional

BD Alaris? Pump Epidural Infusion Set

K221319 · Care Fusion · General Hospital
Jul 2023
Decision
441d
Days
Class 2
Risk

About This 510(k) Submission

K221319 is an FDA 510(k) clearance for the BD Alaris? Pump Epidural Infusion Set, 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 review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K221319 FDA.gov
FDA Decision Cleared 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

Device Classification

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.