DeVilbiss 5 Liter Oxygen Concentrator (555)

The DeVilbiss 5 Liter (555) Oxygen Concentrator is a portable device that produces oxygen-enriched gas by drawing in room air and removing nitrogen through pressure swing adsorption. It delivers supplemental oxygen at adjustable flow rates (0.5–5 liters per minute) to adult patients in home or institutional settings who require oxygen therapy, and is not intended to sustain or support life.

Both the subject device and predicate use pressure swing adsorption with molecular sieves to generate oxygen. Key specifications are equivalent: oxygen concentration 87%–96% (subject) vs. 93%±3% (predicate), continuous adjustable flow 0.5–5 LPM, outlet pressure 8.5 PSIG vs. 38 kPa±5 kPa, and similar alarm functions. Power requirements, noise levels, weight, and dimensions are comparable with minor numerical variations that do not raise safety or effectiveness concerns.

ISO 18562 series (biocompatibility of breathing gas pathways), ISO 10993-17 (toxicological risk assessment), ISO 80601-2-69 (oxygen concentrator safety and performance), IEC 60601-1-2 (electromagnetic compatibility), ANSI/AAMI ES60601-1 (electrical safety), IEC 60601-1-8 (alarm systems), IEC 60601-1-11 (home healthcare environments), IEC 62304 (software life cycle), and ANSI/AAMI/IEC 62366-1 (usability engineering).

The subject device is substantially equivalent to the JUMAO predicate (K230969) because both use identical pressure swing adsorption technology with molecular sieves, serve the same indications for supplemental oxygen delivery to adult patients, share the same product code (CAW), and demonstrate equivalent safety and performance across all key specifications and operating parameters. Performance testing across biocompatibility, electrical safety, EMC, software, and alarm functions confirms the devices are equally safe and effective.