Cleared Traditional

K250325 - BD Alaris Pump Infusion Set

K250325 is an FDA 510(k) clearance for BD Alaris Pump Infusion Set, manufactured by Carefusion (Bd). The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K250325 · Carefusion (Bd) · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
267d
Days
Class 2
Risk

K250325 is an FDA 510(k) clearance for the BD Alaris Pump Infusion Set. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Carefusion (Bd) (San Diego, US). The FDA issued a Cleared decision on October 30, 2025 after a review of 267 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Carefusion (Bd) devices

FDA 510(k) Submission Details - K250325

510(k) Number K250325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 129d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 532
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K250325.
AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
K252543 · Amsino International, Inc. · May 2026
PuraCath Firefly Needleless Connector IT (9005)
K251375 · Puracath Medical, Inc. · Feb 2026
nSet+ Stabilization Set [6426733]
K251257 · Np Medical · Dec 2025
EZ™ IV Administration Set
K251814 · Epic Medical Pte. , Ltd. · Aug 2025
SteadiSet infusion set
K251854 · Tandem Diabetes Care · Aug 2025
Sparta Infusion Set for Insulin
K243841 · Deka Research and Development · Aug 2025