510(k) for Mallinckrodt's respiratory support system:
This article was originally published in Clinica
Executive Summary
Mallinckrodt has received 510(k) clearance from the FDA to use its KnightStar 335 respiratory support system for treating patients over 30kg who suffer respiratory failure in hospitals or institutional settings. The system has been approved previously for other indications including obstructive sleep apnoea and respiratory insufficiency in the home or institutional settings.