FDA applicant

Somnitec, Inc.

Van Nuys, CA4 decisions1991–19910 recalls

FDA records 4 decisions for Somnitec, Inc. (Van Nuys, CA) in 1991: 4 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and LEL (Device, Sleep Assessment). 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Somnitec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Somnitec, 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

Somnitec, Inc.

Which product codes does it file in?

What has FDA decided for it lately?