510(k) Report

FDA applicant

Biovalve Technologies, Inc.

Westborough, MA3 decisions2004–20050 recalls

FDA records 3 decisions for Biovalve Technologies, Inc. (Westborough, MA) from 2004 to 2005: 3 510(k) clearances. Most are in product codes KZE (Injector, Fluid, Non-Electrically Powered) and LZG (Pump, Infusion, Insulin). Its devices cite 3 predicates, 0 of them its own earlier devices. 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 hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Biovalve Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biovalve Technologies, 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?

  • KZEInjector, Fluid, Non-Electrically Powered2decisions
  • LZGPump, Infusion, Insulin1decision

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 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.

  • K050971Biovalve Insulin Delivery Systems (Bids)Biovalve Technologies, Inc. · 20052cite it

What has FDA decided for it lately?

  • K051985Biovalve Mini-Ject Needlefree InjectorBiovalve Technologies, Inc. · 2005
  • K050971Biovalve Insulin Delivery Systems (Bids)Biovalve Technologies, Inc. · 2005
  • K032976Biovalve Miniject Needle-Free Injection System, Model FG-01-001Biovalve Technologies, Inc. · 2004

All 3 as Biovalve Technologies, Inc. →