FDA applicant

Somnetics International, Inc.

New Brighton, MN3 decisions2013–20180 recalls

FDA records 3 decisions for Somnetics International, Inc. (New Brighton, MN) from 2013 to 2018: 3 510(k) clearances. Most are in product codes BZD (Ventilator, Non-Continuous (Respirator)) and BTT (Humidifier, Respiratory Gas, (Direct Patient…). Its devices cite 5 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 Somnetics International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2013high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Somnetics International, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Somnetics International, 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

Other applicant names beginning “Somnetics”

FDA records each applicant name separately; these may or may not be the same firm.

Somnetics International, Inc. (Dba Transcend Inc) 1

Somnetics International, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Somnetics”