FDA applicant

American Biosystems, Inc.

St. Paul, MN4 decisions1988–20000 recalls

FDA records 4 decisions for American Biosystems, Inc. (St. Paul, MN) from 1988 to 2000: 4 510(k) clearances. All are in product code BYI (Percussor, Powered-Electric). Its devices cite 2 predicates, 2 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for American Biosystems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like American Biosystems, 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

American Biosystems, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?