510(k) Report

FDA applicant

Duxbury Scientific, Inc.

Duxbury, MA2 decisions1996–19980 recalls

FDA records 2 decisions for Duxbury Scientific, Inc. (Duxbury, MA) from 1996 to 1998: 2 510(k) clearances. All are in product code CAC (Apparatus, Autotransfusion). 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, anesthesiology panel, where it files most

How often FDA has decided Duxbury Scientific, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Duxbury Scientific, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Duxbury Scientific, 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?

  • CACApparatus, Autotransfusion2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K951592Betatrans I and IIDuxbury Scientific, Inc. · 19961cites it

What has FDA decided for it lately?

  • K982241Betatrans Intraop I and II Model Numbers DS100X and DS10XXDuxbury Scientific, Inc. · 1998
  • K951592Betatrans I and IIDuxbury Scientific, Inc. · 1996

All 2 as Duxbury Scientific, Inc. →