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Oxysure Systems, Inc.

Country not established

Devices
1
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Oxysure Systems, Inc. makes

Oxysure Systems, Inc. manufactures portable oxygen generators, including the OXYSURE Portable Oxygen Generator (Model 615), designed to produce medical-grade oxygen on-demand for patient use.

The company’s products are regulated as Class II devices under FDA requirements and are listed via 510(k) clearance. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Oxysure Systems, Inc., initiated on 2015-06-12. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2015

    • 12 Jun 2015 Z-2253-2015 Class II Terminated Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for a minimum of 15 minutes. Distribution: Nationwide throughout the US and Chile, Trinidad, China Submission number: K052396

Frequently asked questions

How many devices does Oxysure Systems, Inc. have in the registry?

The registry currently lists 1 device for Oxysure Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Oxysure Systems, Inc.'s devices?

Among its 1 most recently registered device, Oxysure Systems, Inc. has devices listed in FDA 510(k) (1 device).

What risk classes do Oxysure Systems, Inc.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Oxysure Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Oxysure Systems, Inc.?

FDA recall records list 1 recall initiated by Oxysure Systems, Inc., the most recent initiated on 2015-06-12. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Oxysure Systems, Inc. in the registry?

The most recently registered devices listed for Oxysure Systems, Inc. include OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615.

Generated automatically from registry data and not verified by a human reviewer.