FDA applicant

Biosynergy, Inc.

Arlington Heights, IL2 decisions1983–19840 recalls

FDA records 2 decisions for Biosynergy, Inc. (Arlington Heights, IL) from 1983 to 1984: 2 510(k) clearances. All are in product code KPD (Strip, Temperature, Forehead, Liquid Crystal). 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 Biosynergy, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biosynergy, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Biosynergy, Inc.

Which product codes does it file in?

What has FDA decided for it lately?