510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221319Substantially Equivalent

BD Alaris™ Pump Epidural Infusion Set

Care Fusion, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221319 is the FDA 510(k) clearance record for BD Alaris™ Pump Epidural Infusion Set, a class II device, cleared for Care Fusion on under FDA product code PWH (Administrations Sets With Neuraxial Connectors). FDA's definition for product code PWH reads: "The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections". FDA records list 34 510(k) clearances for Care Fusion, from to . As of , FDA records show no recalls naming K221319.

Clearance record

Decision date
Received
(441 days to decision)
Product code
PWH Administrations Sets With Neuraxial Connectors
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Care Fusion 10020 Pacific Mesa Blvd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PWH

Trailing 12 months

FDA records hold no clearances under product code PWH in the trailing twelve months.

FDA records show no clearances under product code PWH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PWH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260