510(k) Report

FDA applicant

Medical Depot, Inc.

Appollo Beach, FL4 decisions2001–20081 recall

FDA records 4 decisions for Medical Depot, Inc. (Appollo Beach, FL) from 2001 to 2008: 4 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and CAW (Generator, Oxygen, Portable). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Medical Depot”.

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 Medical Depot, 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

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Medical Depot, 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?

  • CAFNebulizer (Direct Patient Interface)2decisions
  • CAWGenerator, Oxygen, Portable1decision
  • IORWheelchair, Mechanical1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K003344Medical Depot Nebulizer, Model Power Neb 2Medical Depot, Inc. · 20012cite it
  • K080391Drive Solstice Oxygen ConcentratorMedical Depot · 20081cites it

What has FDA decided for it lately?

  • K080391Drive Solstice Oxygen ConcentratorMedical Depot · 20081 recall
  • K012006Medical Depot Power Neb 1Medical Depot, Inc. · 2001
  • K003344Medical Depot Nebulizer, Model Power Neb 2Medical Depot, Inc. · 2001
  • K003783Medical Depot-Wheelchairs, Model Sentra,Astaire and ViperMedical Depot, Inc. · 2001

All 3 as Medical Depot, Inc. →The one decision as Medical Depot →

What has been recalled?

1 recall linked to its devices; the latest:

  • K080391PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000SOct 9, 2017Class II