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PCI on-site oxygen generators win FDA 510(k) clearance

PCI, a provider of on-site gas separation systems, has received the US Food and Drug Administration (FDA) 510(k) clearance to market their oxygen generators or deployable oxygen concentrator systems (DOCS), as medical devices.

PCI said these medical devices generate and deliver USP grade 93% ± 3% oxygen used to disaster relief, crisis response or humanitarian relief situations where bottled or bulk oxygen is not readily available and for hospital backup systems.

The other usages are in local emergencies where disaster has rendered the primary oxygen supply unusable, fill high pressure oxygen cylinders for use in locations remote to the DOCS unit or for ambulatory patient use and OR by trained military personnel in peacetime or wartime support of the Armed Forces.

The commercial line of on-site oxygen generators, DOCS, utilize a proprietary Vacuum Swing Adsorption (VSA) process, to produce oxygen.

The technology offers the lowest operating cost and most reliable oxygen generator in its class, with outputs ranging from 66 liters per minute (280 lbs per day) to 500 liters per minute (1 ton per day) at 93% +/- 3% purity.

The systems are built to be light weight, compact, and turn-key and installation time is measured in hours and not days.