Respond OC Conserving Regulator (130-0800)

The Respond OC Conserving Regulator is a dual-mode oxygen delivery device designed for patients requiring supplemental oxygen at home or during travel. It delivers oxygen either as a continuous flow (2-4 LPM) or in short bursts triggered by the patient's inhalation (1-5 LPM equivalent conserve mode), extending cylinder duration up to 6:1 compared to continuous flow alone.

The device is a pneumatic (non-electric) regulator with a CGA 870 yoke for high-pressure cylinders (300-3000 psig inlet), a sensing diaphragm that detects inhalation, and a click-style flow control knob. It delivers oxygen boluses in the early inhalation phase, has a nominal outlet pressure of 22 PSI, and uses a standard single-lumen nasal cannula up to 7 feet long.

ISO 18562-2 (particulate matter emissions), ISO 18562-3 (VOC emissions with toxicological risk assessment), and ASTM G 175-24 (ignition sensitivity and fault tolerance). Performance testing included accelerated aging, flow comparison, flow regulation, conservation testing, burst pressure, environmental and altitude testing, flow response, and impact testing.

Both the subject device and predicate (Chad Therapeutics Bonsai Model 800) are pneumatic combination regulators with identical indications for use, patient populations, environments, and operating principles—both sense inhalation and deliver pulsed oxygen via nasal cannula with 6:1 conservation ratios. The minor functional difference in bolus delivery timing (subject delivers in first 1/3 versus predicate's first 1/2 of inhalation cycle) represents less than 0.4-second variation across breathing rates (15-30 BPM) and does not raise different safety or effectiveness questions. Bench testing confirms the subject device performs similarly to the predicate across all comparable parameters.