510(k) Report

FDA applicant

Beeken Biomedical, LLC

Stoughton, MA3 decisions2015–20191 recall

FDA records 3 decisions for Beeken Biomedical, LLC (Stoughton, MA) from 2015 to 2019: 3 510(k) clearances. Most are in product codes QSY (Hemostatic Wound Dressing Without Thrombin Or…) and POD (Temporary, Internal Use Hemostatic). Its devices cite 4 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Beeken Biomedical”.

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 Beeken Biomedical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2015: 12016: 12019: 1
2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1
2015high 1 (2021) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Beeken Biomedical, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics2decisions
  • PODTemporary, Internal Use Hemostatic1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K142363Nustat, Nustat XRBeeken Biomedical · 20152cite it

What has FDA decided for it lately?

  • K183190NuStatBeeken Biomedical, LLC · 20191 recall
  • K160578Nustat XRBeeken Biomedical, LLC · 2016
  • K142363Nustat, Nustat XRBeeken Biomedical · 2015

All 2 as Beeken Biomedical, LLC →The one decision as Beeken Biomedical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K183190NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ…Oct 14, 2021Class II