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Validation status of definitive airway management simulators: a systematic review. BACKGROUND: Definitive airway management simulators are widely used for training and evaluating airway management techniques. However, the extent and quality of their validation remain unclear. In this systematic review, we aimed to identify and evaluate studies assessing the validity of airway simulators used in anaesthesia and airway training. METHODS: A comprehensive and systematic literature search was conducted across PubMed, Embase, and Cochrane Library databases up to September 2025, following PRISMA guidelines. Studies were included if they evaluated at least one domain of simulator validity. Methodological quality was assessed using the Joanna Briggs Institute checklist and each simulator was assigned a Level of Recommendation. The review protocol was registered with PROSPERO (CRD420251108102). RESULTS: From 939 studies screened, 17 articles met the inclusion criteria, and 29 different simulators were included. Validation domains varied widely, with most studies assessing only one or two domains. Predictive validity, linking simulator performance to clinical outcomes, was rarely evaluated. High-fidelity simulators, such as ORSIM® and SimMan®, demonstrated the most comprehensive validation across multiple domains. Validation quality did not consistently correlate with simulator fidelity, and several low-fidelity models demonstrated short-term skill transfer comparable with more complex systems. CONCLUSIONS: Definitive airway simulators are commonly used for training and device evaluation yet are rarely subjected to robust validation. These findings highlight the urgent need for a unified validation framework and higher-quality research to ensure simulators used in airway management accurately reflect clinical realities. This has critical implications for educators, training bodies, and institutions relying on simulators for competency development and device assessment. SYSTEMATIC REVIEW PROTOCOL: PROSPERO (CRD420251108102).