Identifiers
- 510(k) Number
- K251770 FDA 510(k)
- FDA Product Code
- BZD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5905 FDA 510(k)
- Regulation Number
- 868.5905 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SleepRes PAP System is a ventilator, non-continuous (respirator) device classified under product code BZD and regulation number 868.5905. It is substantially equivalent to a predicate device and received traditional 510(k) clearance from the FDA. The device is manufactured by Sleepres, Inc. and is intended for use in the treatment of obstructive sleep apnea.
The SleepRes PAP System offers CPAP and APAP therapy modes, providing continuous positive airway pressure or automatic pressure titration to balance efficacy and comfort. It is intended for use in home, hospital or institutional, and sleep center settings. Pressure limits are pre-set by the prescribing clinician.
Frequently asked questions
What is the SleepRes PAP System intended to treat?
The SleepRes PAP System is intended for the treatment of obstructive sleep apnea, as stated in its device description, providing therapy to maintain airway pressure during sleep.
What therapy modes does the SleepRes PAP System provide?
The SleepRes PAP System offers CPAP and APAP therapy modes, delivering continuous positive airway pressure or automatic pressure titration to balance efficacy and patient comfort.
Where can the SleepRes PAP System be used?
The device is intended for use in home, hospital or institutional, and sleep center settings, allowing flexibility based on patient needs and prescribing clinician guidance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FDA clears Kricket PAP device with KPAP from SleepRes, PDF SleepRes, Inc ℅ Paul Dryden Consultant ProMedic, LLC 131 Bay Point Dr ..., SleepRes Launches Kricket PAP Device for Obstructive Sleep Apnea
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251770 | Class II | Active |
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Manufacturer
- Manufacturer
- Sleepres, Inc.
Sources (1)
- FDA 510(k) K251770 24 fields · synced Oct 6, 2026