510(k) Report

FDA applicant

Oceanic Medical Products, Inc.

Atchison, KS4 decisions2000–20080 recalls

FDA records 4 decisions for Oceanic Medical Products, Inc. (Atchison, KS) from 2000 to 2008: 4 510(k) clearances. Most are in product codes BSZ (Gas-Machine, Anesthesia) and CBK (Ventilator, Continuous, Facility Use). Its devices cite 3 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 Oceanic Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Oceanic Medical Products, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • BSZGas-Machine, Anesthesia3decisions
  • CBKVentilator, Continuous, Facility Use1decision

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K010613Magellan-2200, Model 1Oceanic Medical Products, Inc. · 20012cite it
  • K002951Magellan VentilatorOceanic Medical Products, Inc. · 20001cites it

What has FDA decided for it lately?

  • K072420Magellan-2200, Model-3 Anesthesia MachineOceanic Medical Products, Inc. · 2008
  • K060193Magellan-2200 Model -2 Anesthesia Machine, Model 2Oceanic Medical Products, Inc. · 2006
  • K010613Magellan-2200, Model 1Oceanic Medical Products, Inc. · 2001
  • K002951Magellan VentilatorOceanic Medical Products, Inc. · 2000

All 4 as Oceanic Medical Products, Inc. →