Cleared Traditional

K243062 - BD Intelliport System (FDA 510(k) Clearance)

Also includes:
BD Intelliport Reader (516230) BD Intelliport Sensor (516229) BD Intelliport Gateway (516232) BD Intelliport Mount (516233) BD Intelliport Charger (516231)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243062 · Becton Dickinson · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
266d
Days
Class 2
Risk

K243062 is an FDA 510(k) clearance for the BD Intelliport System. Classified as Infusion Safety Management Software (product code PHC), Class II - Special Controls.

Submitted by Becton Dickinson (Franklin Lakes, US). The FDA issued a Cleared decision on June 20, 2025 after a review of 266 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Becton Dickinson devices

Submission Details

510(k) Number K243062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2024
Decision Date June 20, 2025
Days to Decision 266 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: 128d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHC Infusion Safety Management Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
Definition Infusion Safety Management Software Is A Prescription Device Intended For Use With Infusion Pumps And May Include One Or More Of The Following Capabilities: Prepopulation Of Infusion Programming Parameters, Data Retrieval And Analysis For Tracking And Trending, Drug Infusion Error Reduction Algorithms, And Alarm Transmission.
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 - PHC Infusion Safety Management Software

All 9
Devices cleared under the same product code (PHC) and FDA review panel - the closest regulatory comparables to K243062.
LifeShield Infusion Safety Software Suite
K252130 · Icu Medical, Inc. · Apr 2026
LifeShield Infusion Safety Software Suite
K242117 · Icu Medical, Inc. · Apr 2025
Dose IQ Safety Software
K230665 · Baxter Healthcare Corporation · Mar 2024
LifeShield™ Infusion Safety Software Suite
K223606 · Icu Medical, Inc. · Aug 2023
Dose IQ Safety Software
K211124 · Baxter Healthcare Corporation · Aug 2022
Vigilant Software Suite – Vigilant Master Med
K210075 · Fresenius Kabi AG · Mar 2022