510(k) Report

FDA applicant

Vidacare Corporation

Irvine, CA21 decisions2004–201412 recalls

FDA records 21 decisions for Vidacare Corporation (Irvine, CA) from 2004 to 2014: 21 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and KNW (Instrument, Biopsy). Its devices cite 49 predicates, 30 of them its own earlier devices. 12 recalls are linked to its devices.

FDA’s records also spell it “Vidacare, LLC”.

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 Vidacare Corporation’s devices, and how often a recall has named them.

FDA decisions per year

3in 2014

2007: 32008: 12009: 12010: 12012: 22014: 3
2007high 3 (2007) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2021

2014: 12015: 12016: 52017: 12019: 32021: 1
2007high 5 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Vidacare Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMINeedle, Hypodermic, Single Lumen14decisions
  • KNWInstrument, Biopsy3decisions
  • FCFInstrument, Biopsy, Mechanical, Gastrointestinal2decisions
  • FPASet, Administration, Intravascular1decision
  • MOQBattery, Replacement, Rechargeable1decision

Whose devices does it build on?

Its devices cite 49 predicates; 30 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 44 times; 30 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.

  • K032885Vidaport Intraosseous Infusion SystemVidacare Corporation · 20048cite it
  • K052195EZ-Mio Manual DriverVidacare Corporation · 20055cite it
  • K043490PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation · 20054cite it
  • K052408EZ-IOVidacare Corporation · 20054cite it
  • K072045Oncontrol Bone Marrow Biopsy SystemVidacare Corporation · 20073cite it
  • K141117EZ-IO Intraosseous Infusion SystemVidacare, LLC · 20143cite it

What has FDA decided for it lately?

  • K142377The OnControl Bone Marrow Biopsy System by VidacareVidacare, LLC · 20144 recalls
  • K141117EZ-IO Intraosseous Infusion SystemVidacare, LLC · 20143 recalls
  • K132583EZ-IO Intraosseous Infusion SystemVidacare Corporation · 2014
  • K120661The T.a.L.O.N. Intraossous Infusion System by VidacreVidacare Corporation · 20121 recall
  • K113872The Oncontrol Bone Access and Bone Biopsy System by VidacareVidacare Corporation · 20122 recalls
  • K101026Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IOVidacare Corporation · 2010
  • K091140EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IOVidacare Corporation · 20091 recall
  • K081713Vertebral Access System by VidacareVidacare Corporation · 2008

All 19 as Vidacare Corporation →All 2 as Vidacare, LLC →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K113872Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy…Mar 8, 2021Class II
  • K141117Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code…Oct 8, 2019Class II
  • K141117Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code…Oct 8, 2019Class II
  • K141117Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code…Oct 8, 2019Class II
  • K091140Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.Mar 29, 2017Class III
  • K113872ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl…Nov 8, 2016Class II