FDA applicant

Biocoat, Inc.

Horsham, PA2 decisions2003–20060 recalls

FDA records 2 decisions for Biocoat, Inc. (Horsham, PA) from 2003 to 2006: 2 510(k) clearances. Most are in product codes MQK (Labware, Assisted Reproduction) and POV (Semen Analysis Device). Its devices cite 2 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Biocoat, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Biocoat, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?