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    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 CyberLast 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 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.

    Primary references

    3 sources
    Link health: 1 verified 1 bot-blocked 1 needs review· last checked 2026-05-09
    FDA·1CMS·1AdvaMed·1
    1. 1
      FDA — Philips Respironics Recall
      Bot-blocked
      FDAfda.gov
    2. 2
      CMS — Continuous Positive Airway Pressure (CPAP) Therapy NCD 240.4
      Needs review
      CMScms.gov
    3. 3
      AdvaMed - Industry Reports
      Verified
      AdvaMedadvamed.org

    Inline markers like [1] jump to the matching reference above.