FDA applicant

American Biocurve, Inc.

Grand Junction, CO2 decisions2001–20010 recalls

FDA records 2 decisions for American Biocurve, Inc. (Grand Junction, CO) in 2001: 2 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). 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, ophthalmic panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like American Biocurve, 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 Biocurve, Inc.

Which product codes does it file in?

What has FDA decided for it lately?