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510(k) K251770

SleepRes PAP System by Sleepres, Inc. — Product Code BZD

K251770 is an FDA 510(k) premarket notification submitted by Sleepres, Inc. for the device "SleepRes PAP System". The FDA issued a decision of Substantially Equivalent on December 15, 2025. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2025
Date Received
June 10, 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 for product code BZD

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  • K253166 — F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) (April 29, 2026)
  • K252338 — MySleepDash (April 17, 2026)
  • K251847 — Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (January 15, 2026)
  • K253939 — DeltaWave Nasal Pillow System (January 7, 2026)
  • K251657 — Personalized Therapy Comfort Settings (PTCS) (December 5, 2025)
  • K243583 — F&P Nova Nasal Mask (June 18, 2025)
  • K250624 — myAir (May 28, 2025)

FDA data resources