510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K243062Substantially Equivalent

BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)

Becton Dickinson & Co, Franklin Lakes NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243062 is the FDA 510(k) clearance record for BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231), a class II device, cleared for Becton Dickinson on under FDA product code PHC (Infusion Safety Management Software). FDA's definition for product code PHC reads: "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...". FDA records list 345 510(k) clearances for Becton Dickinson, from to . As of , FDA records show no recalls naming K243062.

Clearance record

Decision date
Received
(266 days to decision)
Product code
PHC Infusion Safety Management Software
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Becton Dickinson 1 Becton Dr., Franklin Lakes NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PHC

Trailing 12 months
1 clearance under product code PHC in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PHC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260