510(k) Report

FDA applicant

Akos Biomedical, Inc.

San Diego, CA1 decision1997–19970 recalls

FDA records 1 decision for Akos Biomedical, Inc. (San Diego, CA) in 1997: 1 510(k) clearance. All are in product code FAM (Sigmoidoscope And Accessories, Flexible/Rigid). Its devices cite 14 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Akos Biomedical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Akos Biomedical, 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

Which product codes does it file in?

  • FAMSigmoidoscope And Accessories, Flexible/Rigid1decision

Whose devices does it build on?

Its devices cite 14 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K964131EndoscopeAkos Biomedical, Inc. · 1997

The one decision as Akos Biomedical, Inc. →