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510(k) K250624

myAir by ResMed Corp — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2025
Date Received
March 3, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by ResMed Corp

  • K251657 — Personalized Therapy Comfort Settings (PTCS) (December 5, 2025)
  • K241939 — EasyCare Tx 2 (September 27, 2024)
  • K241216 — myAir (September 26, 2024)
  • K200565 — Galapogos (January 17, 2021)
  • K183512 — Moore Park Mask (May 7, 2019)
  • K180497 — Scone Mask (June 15, 2018)
  • K172875 — Astral 100/150 (April 26, 2018)
  • K170924 — AirFit F20 (January 3, 2018)
  • K171212 — AirFit N20 (September 28, 2017)
  • K161492 — Juno VPAP ST-A (January 19, 2017)

Other clearances for product code BZD

  • K251847 — Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (January 15, 2026)
  • K253939 — DeltaWave Nasal Pillow System (January 7, 2026)
  • K251770 — SleepRes PAP System (December 15, 2025)
  • K251657 — Personalized Therapy Comfort Settings (PTCS) (December 5, 2025)
  • K243583 — F&P Nova Nasal Mask (June 18, 2025)
  • K243023 — WiZARD 520 Full Face Mask (May 23, 2025)
  • K242547 — AirFit F20 Mask System; AirFit F20 NM Mask System (May 19, 2025)
  • K242935 — Respiration Data Management Software (PAP Link PC) (January 15, 2025)
  • K243225 — Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-0 (December 31, 2024)
  • K241830 — Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face V (October 18, 2024)