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

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K243062 ↗

FDA Product Code

PHC

Models / Variants

BD Intelliport System

BD Intelliport Reader (516230)

BD Intelliport Sensor (516229)

BD Intelliport Gateway (516232)

BD Intelliport Mount (516233)

BD Intelliport Charger (516231)

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Bd Phoenix Automated Microbiology System-Vancomycin Gram Positive

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  FDA 510(k) K030677 Active Cleared 1 Apr 2003

• BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit

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  FDA 510(k) K152870 Active Cleared 27 Oct 2015

• Bd Phoenix Automated Microbiology System-Pipercillin (Gn) 0.5-128 Ug/Ml

  Class II

  FDA 510(k) K041572 Active Cleared 12 Aug 2004

• Bd Probetec Neisseria Gonorrhoeae (Gc) Qx Amplified DNA Assay

  Class II

  FDA 510(k) K090827 Active Cleared 27 May 2009

• Bd Pen Needle

  Class II

  FDA 510(k) K051899 Active Cleared 13 Sep 2005

• Bd Phoenix Automated Microbiology System, Vancomycin (Strep) 0.0625 -32 Ug/Ml

  Class II

  FDA 510(k) K050745 Active Cleared 29 Apr 2005

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