510(k) Report

FDA applicant

Avalon Laboratories, LLC

Rancho Dominguez, CA3 decisions2008–20081 recall

FDA records 3 decisions for Avalon Laboratories, LLC (Rancho Dominguez, CA) in 2008: 3 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DRE (Dilator, Vessel, For Percutaneous…). Its devices cite 3 predicates, 0 of them its own earlier devices. 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, cardiovascular panel, where it files most

How often FDA has decided Avalon Laboratories, LLC’s devices, and how often a recall has named them.

FDA decisions per year

3in 2008

2008: 3
2008high 3 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2008high 1 (2020) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Avalon Laboratories, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2decisions
  • DREDilator, Vessel, For Percutaneous Catheterization1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 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.

  • K081820Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FRAvalon Laboratories, LLC · 20085cite it
  • K081940Avalon Elite Vascular Access KitAvalon Laboratories, LLC · 20083cite it

What has FDA decided for it lately?

  • K081940Avalon Elite Vascular Access KitAvalon Laboratories, LLC · 20081 recall
  • K081820Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FRAvalon Laboratories, LLC · 2008
  • K081933Avalon Elite Multi-Port Venous Femoral Catheter, 20FR, 22FR, 24FR, 26FR, 28FRAvalon Laboratories, LLC · 2008

All 3 as Avalon Laboratories, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K081940Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039Feb 20, 2020Class II

Other applicant names beginning “Avalon”

FDA records each applicant name separately; these may or may not be the same firm.

Avalon Biomed, Inc. 3Avalon Technology Corp. 2Avalon Biomedical (Shenzhen) Limited 1