510(k) Report

FDA applicant

Global Blood Resources, LLC

Windsor, CT2 decisions2003–20030 recalls

FDA records 2 decisions for Global Blood Resources, LLC (Windsor, CT) in 2003: 2 510(k) clearances. Most are in product codes DTN (Reservoir, Blood, Cardiopulmonary Bypass) and DWF (Catheter, Cannula And Tubing, Vascular…). No 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, cardiovascular panel, where it files most

How often FDA has decided Global Blood Resources, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Global Blood Resources, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Global Blood Resources, LLC 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?

  • DTNReservoir, Blood, Cardiopulmonary Bypass1decision
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1decision

What has FDA decided for it lately?

  • K031151TS3 Tubing SetGlobal Blood Resources, LLC · 2003
  • K031150Hemobag, Model HBBSD2000Global Blood Resources, LLC · 2003

All 2 as Global Blood Resources, LLC →