510(k) Report

FDA applicant

Oxysure Systems, Inc.

Frisco, TX1 decision2005–20051 recall

FDA records 1 decision for Oxysure Systems, Inc. (Frisco, TX) in 2005: 1 510(k) clearance. All are in product code CAW (Generator, Oxygen, Portable). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Oxysure Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oxysure Systems, Inc. since 2007.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Oxysure 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?

  • CAWGenerator, Oxygen, Portable1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K052396Oxysure Portable Oxygen Generator, Model 615Oxysure Systems, Inc. · 20053cite it

What has FDA decided for it lately?

  • K052396Oxysure Portable Oxygen Generator, Model 615Oxysure Systems, Inc. · 20051 recall

The one decision as Oxysure Systems, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K052396OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.Jun 12, 2015Class II