Cleared Traditional

BD Alaris? Pump Infusion Sets

K221327 · Care Fusion · General Hospital
Jul 2023
Decision
441d
Days
Class 2
Risk

About This 510(k) Submission

K221327 is an FDA 510(k) clearance for the BD Alaris? Pump Infusion Sets, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), 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 K221327 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 FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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