--- title: "Respiratory Devices, Definition | MedTech Terms" description: "Devices for managing breathing and airway conditions. 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Respiratory Devices [All terms](/terms) Market Segments [Strategic Landscape](/ecosystems/strategic-landscape) # Respiratory Devices Devices for managing breathing and airway conditions. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Respiratory devices include [CPAP](/terms/sleep-respiratory-devices)/BiPAP for sleep apnea (ResMed, Philips), home oxygen concentrators, ventilators, nebulizers, inhaler delivery devices, and emerging implantable phrenic-nerve stimulators for central sleep apnea. What the regulation says Respiratory devices are controlled medical devices subject to specific regulatory requirements. The FDA classifies many respiratory devices, such as continuous positive airway pressure ( [CPAP](/terms/sleep-respiratory-devices)) devices and ventilators, as Class II or Class III devices, requiring premarket notification (510(k)) or [premarket approval](/terms/pma) (PMA) respectively. EU [MDR](/terms/mdr-reporting) Annex XVI lists certain devices without an intended medical purpose, including some aesthetic respiratory masks, which still fall under its scope. Requirements for these devices include adherence to quality system regulations like 21 CFR Part 820 and [ISO 13485](/terms/iso-13485), as well as risk management per [ISO 14971](/terms/iso-14971). ## What this means in practice Philips Respironics recall (2021–2024) reshaped the [CPAP](/terms/sleep-respiratory-devices) market. Connected CPAP data (myAir, AirView) drives adherence and payer reauthorization. ## Examples - A manufacturer developing a new CPAP device must submit a 510(k) to the FDA, demonstrating substantial equivalence to a predicate device. - A company designing an internet-connected ventilator needs to implement robust cybersecurity controls and conduct penetration testing to meet regulatory expectations. - Following a reported issue with nebulizer malfunction, the manufacturer initiates a field safety corrective action, documenting the process according to ISO 13485 procedures. Common pitfalls - • Failing to identify all applicable classifications and regulatory pathways for a respiratory device across different markets can lead to significant delays. - • Underestimating the cybersecurity risks associated with connected respiratory devices, particularly those transmitting patient data, is a common pitfall. - • Not adequately addressing usability and human factors engineering during the design and development of respiratory devices can result in patient harm or misuse. - • Overlooking post-market surveillance requirements for respiratory devices, especially in light of widespread recalls, can lead to enforcement actions and reputational damage. - • Incorrectly assuming that software components of a respiratory device do not require separate regulatory consideration is a mistake quality professionals make. ## Frequently asked questions What cybersecurity considerations are critical for connected respiratory devices? Connected respiratory devices must protect sensitive patient health information (PHI) in transit and at rest. Manufacturers should address risks such as unauthorized access, data breaches, and denial-of-service attacks, aligning with FDA's cybersecurity guidance and [IEC 81001-5-1](/terms/iec-81001-5-1) for health software and health IT systems safety, effectiveness and security. How do regulatory requirements differ for home-use versus clinical-use respiratory devices? What is the role of post-market surveillance for respiratory devices? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Market Segments ENT Devices Devices for ear, nose, and throat conditions. ](/terms/ent-devices) ### More in Market Segments · Same category [ Market Segments Aesthetic & Energy-Based Devices Lasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions. ](/terms/aesthetics-energy-devices)[ Market Segments AI Imaging Software Software that analyzes medical images to triage, detect, or quantify disease. ](/terms/ai-imaging)[ Market Segments Cardiac Rhythm Management(CRM) Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors. ](/terms/cardiac-rhythm-management)[ Market Segments Cardiovascular Devices Devices for diagnosing, monitoring, or treating cardiovascular disease. ](/terms/cardiovascular) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Strategic Landscape](/ecosystems/strategic-landscape) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ATS· 1 MedTech Europe· 1 MedTech Dive· 1 1. [1 American Thoracic Society Verified ATS · thoracic.org ](https://www.thoracic.org/) 2. [2 MedTech Europe - Facts & Figures Verified MedTech Europe · medtecheurope.org ](https://www.medtecheurope.org/datahub/) 3. [3 MedTech Dive Verified MedTech Dive · medtechdive.com ](https://www.medtechdive.com/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building a connected device in this segment? Blue Goat Cyber specializes in MedTech cybersecurity across imaging, cardiac, IVD, surgical, and other connected segments. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Market Segments Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=respiratory-devices) Learn in 60 seconds Card Lesson Quiz Devices for managing breathing and airway conditions. - · Philips Respironics recall (2021–2024) reshaped the CPAP market. - · Connected CPAP data (myAir, AirView) drives adherence and payer reauthorization. Remember this Watch out: Failing to identify all applicable classifications and regulatory pathways for a respiratory device across different markets can lead to significant delays. Related terms - [ENT Devices ](/terms/ent-devices) You may also need Auto-suggested from Market Segments and shared keywords. - [Sleep & Respiratory Devices ](/terms/sleep-respiratory-devices) - [Neuromodulation ](/terms/neuromodulation) - [Wound Care ](/terms/wound-care) - [Drug Delivery Devices ](/terms/drug-delivery-devices) - [Ophthalmology Devices ](/terms/ophthalmology-devices) - [Wearable Medical Devices ](/terms/wearables) [All Market Segments terms](/terms?cat=Market%20Segments) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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