Heated Breathing Tube

The Heated Breathing Tube is a single-patient, adult-use device for non-invasive respiratory therapy such as CPAP/BiPAP. It connects positive pressure ventilation equipment to delivery interfaces (masks, nasal cannula, trachea cannula) and includes internal heating to prevent condensation of therapy air in the tubing.

Not stated in this summary. (Note: The document provided contains a 510(k) summary for a Compressor Nebulizer device K243468, not for the Heated Breathing Tube K243244. The clearance letter references the Heated Breathing Tube but does not include detailed technical characteristics in the enclosed materials shown.)

The document does not provide specific test standards for the Heated Breathing Tube; however, the clearance letter references general FDA regulatory requirements under 21 CFR Part 820 (Quality System regulation) and indicates devices may be subject to standards per 21 CFR Parts 800–898.

The FDA determined substantial equivalence based on comparison to legally marketed predicate devices predating May 28, 1976, or reclassified devices not requiring PMA approval. The device operates within the established regulatory framework for breathing system heaters (21 CFR 868.5270, Class II), and no new safety or effectiveness concerns are raised by its intended use in non-invasive respiratory therapy.