Data / Medical devices / United States / Carefusion
Carefusion: FDA-registered device maker in San Diego, CA, United States, 33 510(k) clearances
Carefusion is registered with the FDA (registration 3012410077) in San Diego, CA, United States. It lists 7 device types. The FDA files 33 510(k) clearances under its listings, the newest dated October 30, 2025. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3012410077
- Address
- 3750 Torrey View Court, San Diego, CA, United States, 92130
- Owner or operator
- CareFusion (10069801)
- Roles
- Specification developer
- First device listed
- April 14, 2020
- Registered through
- 2026
- Brand names listed
- BD Alaris Infusion Set, BD Alaris Pump Infusion Set, BD Male/Female Luer Lock Cap, BD SmartSite Gravity Blood Set, BD SmartSite Vial Access Device, BD SmartSite Needle-Free Connector, BD Texium Needle-Free Syringe, Blood Collection Assembly and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | 2 | Specification developer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Specification developer | accessdata.fda.gov |
| Set, Blood Transfusion | BRZ | 2 | Specification developer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Specification developer | accessdata.fda.gov |
| Stopcock, I.V. Set | FMG | 2 | Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 30, 2025 | K250325 | BD Alaris Pump Infusion Set | FPA | Substantially Equivalent | Carefusion (Bd) | accessdata.fda.gov |
| March 6, 2024 | K233021 | BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device | LHI | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| September 25, 2023 | K231888 | BD Texium Needle-Free Syringe | FMF | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| July 21, 2023 | K221327 | BD Alaris Pump Infusion Sets | FPA | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| April 7, 2023 | K223088 | BD SmartSite Needle-Free Connector | FPA | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| March 24, 2023 | K223076 | BD Texium Closed Male Luer | ONB | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| July 19, 2017 | K171957 | MaxZero Extension Sets with Needless Connector | FPA | Substantially Equivalent | Carefusion 303, Inc. | accessdata.fda.gov |
| September 19, 2014 | K142527 | Extension Set with BD Q-Syte Luer Access Split Septum | FPA | Substantially Equivalent | Acacia, Inc. | accessdata.fda.gov |
| April 15, 2014 | K140831 | MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR | FPA | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| August 29, 2013 | K132413 | MZ1000 | FPA | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| December 9, 2008 | K083472 | MEDEGEN PRESSURE RATED EXTENSION SETS | FPA | Substantially Equivalent | Medegen, Inc. | accessdata.fda.gov |
| September 25, 2007 | K072542 | MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR | FPA | Substantially Equivalent | Medegen Medical Manufacturing System | accessdata.fda.gov |
| July 26, 2006 | K061285 | SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS | FPA | Substantially Equivalent | Cardinal Health, Alaris Products | accessdata.fda.gov |
| December 23, 2005 | K052790 | SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD | LHI | Substantially Equivalent | Cardinal Health, Alaris Products | accessdata.fda.gov |
| August 16, 2005 | K051930 | DRUG ACCESS SPIKE | FMF | Substantially Equivalent | Medegen Medical Manufacturing Services | accessdata.fda.gov |
| June 22, 2005 | K051499 | INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET | FPA | Substantially Equivalent | Medegen Medical Manufacturing Services | accessdata.fda.gov |
| April 1, 2005 | K050115 | BLOOD HAND PUMP ADMINISTRATION SET | BRZ | Substantially Equivalent | Cardinal Health, Alaris Products | accessdata.fda.gov |
| August 6, 2002 | K022209 | ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS | FPA | Substantially Equivalent | Alaris Medical Systems, Inc. | accessdata.fda.gov |
| April 16, 2002 | K013621 | BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 | FPA | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| November 2, 1999 | K993147 | DECAP | FPA | Substantially Equivalent | The Kipp Group | accessdata.fda.gov |
| June 3, 1998 | K974363 | BECTON DICKINSON BLUNT PLASTIC CANNULA | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| January 22, 1998 | K974006 | BECTON DICKINSON TWINPAK | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| January 13, 1998 | K974083 | CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS | FMG | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
| April 21, 1997 | K970485 | SMARTSITE ACCESS PIN | FPA | Substantially Equivalent | Ivac Medical Systems | accessdata.fda.gov |
| April 4, 1996 | K960280 | IVAC NEEDLE FREE VALVE ADMINISTRATION SETS | FPA | Substantially Equivalent | Y | accessdata.fda.gov |
| February 14, 1995 | K944320 | VENTED/NON-VENTED GEMINI ADMINISTRATION SET | FPA | Substantially Equivalent | Imed Corp. | accessdata.fda.gov |
| February 12, 1993 | K924439 | BECTON DICKINSON INTERLINK VIAL ACCESS CANNULA | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| July 12, 1988 | K882302 | IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080 | FPA | Substantially Equivalent | Y | accessdata.fda.gov |
| February 18, 1982 | K820278 | INTRAVASCULAR ADMINISTRATION SET | FPA | Substantially Equivalent | Y | accessdata.fda.gov |
| August 25, 1981 | K811885 | 30-30-2 700 SYRINGE EXTENSION SET | FPA | Substantially Equivalent | Y | accessdata.fda.gov |
| May 29, 1979 | K790582 | INTRAVASCULAR ADMINISTRATION SET | FPA | Substantially Equivalent | Y | accessdata.fda.gov |
| March 6, 1979 | K790108 | FILTERSET 0.22, I.V. PUMP | FPA | Substantially Equivalent | Imed Corp. | accessdata.fda.gov |
| February 21, 1978 | K780130 | BURETTE INTRAVENOUS ADMIN. SETS. | FPA | Substantially Equivalent | Y | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 1, 2022 | 90707 | Class II | Ongoing | BD MaxGuard Extension Set with 4-way stopcock, REF: M4058 | Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker. | accessdata.fda.gov |
| August 2, 2021 | 88203 | Class II | Ongoing | BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E | Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device. | accessdata.fda.gov |
| June 9, 2021 | 88104 | Class II | Terminated | MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration. | A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Set, I.V. Fluid Transfer
- All makers of Set, Blood Transfusion
- All makers of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- All makers of Syringe, Piston
Updated October 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.