FDA applicant

Summit TO Sea

Mound, MN1 decision2008–20080 recalls

FDA records 1 decision for Summit TO Sea (Mound, MN) in 2008: 1 510(k) clearance. All are in product code CBF (Chamber, Hyperbaric). Its devices cite 3 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, anesthesiology panel, where it files most

How often FDA has decided Summit TO Sea’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Summit TO Sea by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Summit TO Sea’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 “Summit”

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

Summit Medical, Inc. 14 Summit World Trade Corp. 10 Summit Industries, Inc. 8 Summit Doppler Systems, Inc. 7 Summit Nuclear 6 Summit Technology, Inc. 5 Summit Glove, Inc. 5 Summit Medical Products, Inc. 4 Summit Optics, Inc. 2 Summit Spine 2 Summit Medventures 2 Summit Durable Medical Equipment, Inc. 1

Summit TO Sea

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Summit”