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510(k) K243062

BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) by Becton Dickinson — Product Code PHC

K243062 is an FDA 510(k) premarket notification submitted by Becton Dickinson for the device "BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)". The FDA issued a decision of Substantially Equivalent on June 20, 2025. The device falls under product code PHC (Infusion Safety Management Software), a Class II device regulated under 21 CFR 880.5725. Becton Dickinson has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2025
Date Received
September 27, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Infusion Safety Management Software
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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.

Other clearances by Becton Dickinson

  • K161810 — BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a P (February 9, 2017)
  • K161306 — BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Pl (August 8, 2016)
  • K113241 — BD EMERALD SINGLE USE, HYPODERMIC SYRINGE (November 28, 2011)
  • K041478 — BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR (October 28, 2004)
  • K042061 — 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE (August 26, 2004)

Other clearances for product code PHC

  • K252130 — LifeShield Infusion Safety Software Suite (April 2, 2026)
  • K242117 — LifeShield Infusion Safety Software Suite (April 2, 2025)
  • K230665 — Dose IQ Safety Software (March 29, 2024)
  • K223606 — LifeShield™ Infusion Safety Software Suite (August 24, 2023)
  • K211124 — Dose IQ Safety Software (August 30, 2022)
  • K210075 — Vigilant Software Suite – Vigilant Master Med (March 1, 2022)
  • K182092 — BD Intelliport System (April 30, 2019)
  • K141474 — BECTON DICKINSON INTELLIPORT SYSTEM (December 18, 2014)
  • K141193 — MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSI (July 25, 2014)

FDA data resources