510(k) Report

FDA applicant

H.W. Andersen Products, Inc.

Oyster Bay, NY5 decisions1987–19940 recalls

FDA records 5 decisions for H.W. Andersen Products, Inc. (Oyster Bay, NY) from 1987 to 1994: 5 510(k) clearances. Most are in product codes GBS (Catheter, Ventricular, General & Plastic Surgery) and BSS (Tube, Nasogastric). 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, general and plastic surgery panel, where it files most

How often FDA has decided H.W. Andersen Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for H.W. Andersen Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — H.W. Andersen Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like H.W. Andersen Products, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GBSCatheter, Ventricular, General & Plastic Surgery3decisions
  • BSSTube, Nasogastric1decision
  • FGEStents, Drains And Dilators For The Biliary Ducts1decision

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.

  • K935688AN-10S Andersen Tube with StyletH.W. Andersen Products, Inc. · 19942cite it

What has FDA decided for it lately?

  • K935688AN-10S Andersen Tube with StyletH.W. Andersen Products, Inc. · 1994
  • K872458AN3200 Doubilet DrainH.W. Andersen Products, Inc. · 1987
  • K872460AN3000 Mahoney DrainH.W. Andersen Products, Inc. · 1987
  • K872459AN3100 Mulholland DrainH.W. Andersen Products, Inc. · 1987
  • K872457AN3500 Worth DrainH.W. Andersen Products, Inc. · 1987

All 5 as H.W. Andersen Products, Inc. →