--- title: "Sleep & Respiratory Devices, Definition | MedTech Terms" description: "Devices for diagnosis and treatment of sleep-disordered breathing and chronic respiratory disease, CPAP, BiPAP, ventilators, and home sleep tests." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/sleep-respiratory-devices#term", "name": "Sleep & Respiratory Devices", "alternateName": [ "CPAP", "BiPAP", "Sleep apnea devices" ], "description": "The sleep & respiratory segment covers home sleep test (HST) devices, polysomnography systems, CPAP and BiPAP/auto-titrating PAP, adaptive servo-ventilation, home and ICU ventilators, and oxygen concentrators. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Market Segments](/terms?cat=Market%20Segments) 6. / 7. Sleep & Respiratory Devices [All terms](/terms) Market Segments [Strategic Landscape](/ecosystems/strategic-landscape) # Sleep & Respiratory Devices Devices for diagnosis and treatment of sleep-disordered breathing and chronic respiratory disease, CPAP, BiPAP, ventilators, and home sleep tests. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 9, 2026 ## Definition The sleep & respiratory segment covers home sleep test (HST) devices, polysomnography systems, CPAP and BiPAP/auto-titrating PAP, adaptive servo-ventilation, home and ICU ventilators, and oxygen concentrators. The June 2021 Philips Respironics recall of millions of CPAP/BiPAP devices over PE-PUR foam degradation is the largest medical-device recall in MedTech history and reshaped the segment's competitive structure. What the regulation says CPAP/BiPAP are Class II 510(k) under product codes BZD/MNT. Ventilators span Class II and Class III. The Philips recall was a Class I recall under 21 CFR Part 806 with a related FDA consent decree (April 2024). ## What this means in practice DME reimbursement ( [HCPCS](/terms/hcpcs) E0601 for CPAP) and supplier compliance (adherence-monitoring requirements) drive product design. Adherence monitoring data is now a routine payer requirement. Common pitfalls - • Sourcing sound-abatement foams without long-term off-gassing characterization (the Philips lesson). - • Treating adherence data telemetry as optional, payers require it. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Reimbursement Durable Medical Equipment, Prosthetics, Orthotics, and Supplies(DMEPOS) Medicare benefit category covering durable medical equipment, prosthetics, orthotics, and supplies, billed under HCPCS Level II codes through DME MACs. ](/terms/dmepos)[ Post-Market Post-Market Surveillance(PMS) Activities to monitor device safety and performance after market release. ](/terms/post-market-surveillance) ### 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 FDA· 1 AdvaMed· 1 MedTech Europe· 1 1. [1 FDA, Philips Respironics Recall Verified FDA · fda.gov ](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/philips-issues-recall-notification-mitigate-potential-health-risks-related-sound-abatement-foam) 2. [2 AdvaMed - Industry Reports Verified AdvaMed · advamed.org ](https://www.advamed.org/our-work/) 3. [3 MedTech Europe - Facts & Figures Verified MedTech Europe · medtecheurope.org ](https://www.medtecheurope.org/datahub/) 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 5/9/2026 [Compare with another term](/compare?a=sleep-respiratory-devices) Learn in 60 seconds Card Lesson Quiz Devices for diagnosis and treatment of sleep-disordered breathing and chronic respiratory disease, CPAP, BiPAP, ventilators, and home sleep tests. - · DME reimbursement (HCPCS E0601 for CPAP) and supplier compliance (adherence-monitoring requirements) drive product design. - · Adherence monitoring data is now a routine payer requirement. Remember this Watch out: Sourcing sound-abatement foams without long-term off-gassing characterization (the Philips lesson). Related terms - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Durable Medical Equipment, Prosthetics, Orthotics, and Supplies(DMEPOS) ](/terms/dmepos) - [Post-Market Surveillance(PMS) ](/terms/post-market-surveillance) You may also need Auto-suggested from Market Segments and shared keywords. - [Respiratory Devices ](/terms/respiratory-devices) - [In Vitro Diagnostics (Segment)(IVD) ](/terms/ivd-segment) - [Urology Devices ](/terms/urology-devices) - [Cardiac Rhythm Management(CRM) ](/terms/cardiac-rhythm-management) - [Electrophysiology(EP) ](/terms/electrophysiology) - [Endoscopy Devices ](/terms/endoscopy-devices) [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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