510(k) Report

FDA applicant

Care Fusion

Vernon Hills, IL34 decisions2010–202423 recalls

FDA records 34 decisions for Care Fusion (Vernon Hills, IL) from 2010 to 2024: 34 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and HRX (Arthroscope). Since 2016 its 510(k)s took a median of 207 days from receipt to decision, against 243 for FDA’s reviews in the same codes and years. Its devices cite 76 predicates, 17 of them its own earlier devices. 23 recalls are linked to its devices, 16 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Care Fusion’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2010: 12011: 32012: 52013: 42014: 32015: 42016: 32017: 32020: 12023: 62024: 1
2010high 6 (2023) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

2in 2025

2011: 12013: 1, 1 Class I2015: 1, 1 Class I2016: 12, 12 Class I2019: 12020: 12021: 42025: 2, 2 Class I
2010high 12 (2016) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Care Fusion by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FPASet, Administration, Intravascular6decisions
  • HRXArthroscope4decisions
  • DWMApparatus, Suction, Patient Care4decisions
  • PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling4decisions
  • KNWInstrument, Biopsy2decisions
  • CBKVentilator, Continuous, Facility Use2decisions

Also: CAF (2), NDN (2), ONB (1), LHI (1), CCK (1), BZE (1).

How long do its 510(k) reviews take?

Since 2016, its 10 510(k)s took a median of 207 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 243 days; 3 of its 10 were faster than that.

Whose devices does it build on?

Its devices cite 76 predicates; 17 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 51 times; 17 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K132413MZ1000Care Fusion · 20136cite it
  • K140831Maxzero Extension Set with Needless ConnectorCare Fusion · 20146cite it
  • K141552Achieve Programmable Auomated Biopsy SystemsCare Fusion · 20145cite it
  • K103064Avamax Vertebral BalloonCare Fusion · 20114cite it
  • K093463Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Care Fusion · 20104cite it
  • K171531Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle…Care Fusion · 20173cite it

What has FDA decided for it lately?

  • K233021BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access DeviceCare Fusion · 2024
  • K231888BD Texium™ Needle-Free SyringeCare Fusion · 2023
  • K221327BD Alaris™ Pump Infusion SetsCare Fusion · 2023
  • K221319BD Alaris™ Pump Epidural Infusion SetCare Fusion · 2023
  • K223101BD Secondary Infusion SetCare Fusion · 2023
  • K223088BD SmartSite™ Needle-Free ConnectorCare Fusion · 2023
  • K223076BD Texium™ Closed Male LuerCare Fusion · 2023
  • K201155PleurX Peritoneal Catheter SystemCare Fusion · 2020

All 34 as Care Fusion →

What has been recalled?

23 recalls linked to its devices; the latest:

  • K151303Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog…Apr 10, 2025Class I
  • K151303Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog…Apr 10, 2025Class I
  • K171531Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration…Aug 24, 2021Class II
  • K171531Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11…Aug 24, 2021Class II
  • K171531TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition…Jun 23, 2021Class II
  • K171531EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G…Jun 23, 2021Class II