510(k) Report

FDA applicant

Nautilus Environmedical Systems, Inc.

Walker, MI2 decisions1983–19850 recalls

FDA records 2 decisions for Nautilus Environmedical Systems, Inc. (Walker, MI) from 1983 to 1985: 2 510(k) clearances. 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 Nautilus Environmedical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nautilus Environmedical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Nautilus Environmedical Systems, 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?

  • CBFChamber, Hyperbaric2decisions

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K832127Nautilus Monoplace Hyperbaric UnitNautilus Environmedical Systems, Inc. · 19834cite it

What has FDA decided for it lately?

  • K850563Sechrist Ventilator/Nautilus Chamber CombinationNautilus Environmedical Systems, Inc. · 1985
  • K832127Nautilus Monoplace Hyperbaric UnitNautilus Environmedical Systems, Inc. · 1983

All 2 as Nautilus Environmedical Systems, Inc. →

Other applicant names beginning “Nautilus”

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

Nautilus Sports/Medical Industries, Inc. 1