Home / 510(k) Clearances / K243225

510(k) K243225

Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) by Genadyne Biotechnologies, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2024
Date Received
October 8, 2024
Clearance Type
Special
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 Genadyne Biotechnologies, Inc.

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  • K233614 — Genadyne DUO NPWT (December 23, 2024)
  • K221888 — Genadyne Hybrid Foam Dressings (June 12, 2023)
  • K221891 — UNO Negative Pressure Wound Therapy System (December 14, 2022)
  • K210107 — Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System (June 1, 2022)
  • K190028 — UNO 30 (January 15, 2020)
  • K182722 — XLR8 Abdominal Wound Dressing Kit (September 27, 2019)
  • K180840 — UNO Negative Pressure Wound Therapy System (November 30, 2018)
  • K161599 — UNO Negative Pressure Wound Therapy System (April 6, 2017)
  • K143726 — XLR8 PLUS (XLR8+) (June 19, 2015)

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)
  • K250624 — myAir (May 28, 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)
  • K241830 — Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face V (October 18, 2024)