Cleared Traditional

BD Alaris Pump Infusion Set

K250325 · Carefusion (Bd) · General Hospital

Oct 2025

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K250325 is an FDA 510(k) clearance for the BD Alaris Pump Infusion Set, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Carefusion (Bd) (San Diego, US). The FDA issued a Cleared decision on October 30, 2025, 267 days after receiving the submission on February 5, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K250325 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 2025
Decision Date	October 30, 2025
Days to Decision	267 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF