510(k) Report

FDA applicant

Neostar Medical Technologies, Inc.

King Of Prussia, PA4 decisions1995–19961 recall

FDA records 4 decisions for Neostar Medical Technologies, Inc. (King Of Prussia, PA) from 1995 to 1996: 4 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and DYB (Introducer, Catheter). 1 recall is linked to its devices.

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 Neostar Medical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neostar Medical Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Neostar Medical Technologies, Inc. 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?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2decisions
  • DYBIntroducer, Catheter1decision
  • KOCAccessories, Blood Circuit, Hemodialysis1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K941851Dual Lumen Catheter (DLC) TrayNeostar Medical Technologies, Inc. · 19952cite it

What has FDA decided for it lately?

  • K960625Spreadable Sheath Introducer SetNeostar Medical Technologies, Inc. · 1996
  • K944660Acute Central Venous Access Catheter TrayNeostar Medical Technologies, Inc. · 1995
  • K941851Dual Lumen Catheter (DLC) TrayNeostar Medical Technologies, Inc. · 19951 recall
  • K944511Acute Central Venous Access Catheter (Acvac)Neostar Medical Technologies, Inc. · 1995

All 4 as Neostar Medical Technologies, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K941851Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12…May 28, 2004