510(k) Report

FDA applicant

Sea-Long Medical Systems, Inc.

Louisville, KY1 decision2001–20010 recalls

FDA records 1 decision for Sea-Long Medical Systems, Inc. (Louisville, KY) in 2001: 1 510(k) clearance. All are in product code CBF (Chamber, Hyperbaric). 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 Sea-Long Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sea-Long Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • CBFChamber, Hyperbaric1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K010659Sea-Long Medical Treatment HoodSea-Long Medical Systems, Inc. · 20011cites it

What has FDA decided for it lately?

  • K010659Sea-Long Medical Treatment HoodSea-Long Medical Systems, Inc. · 2001

The one decision as Sea-Long Medical Systems, Inc. →