SleepWeaver Advance Pediatric Nasal CPAP Mask
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151683 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 SleepWeaver Advance Pediatric Nasal CPAP Mask is a non-invasive interface designed to deliver positive airway pressure ventilation therapy. It functions as a nasal mask to facilitate the delivery of continuous positive airway pressure or bi-level therapy to the patient.
This device is intended for single-patient use in both home and hospital or institutional environments. It is authorized under FDA 510K clearance and is categorized as a class 2 non-continuous ventilator.
Frequently asked questions
What is the intended use of the SleepWeaver Advance Pediatric Nasal CPAP Mask?
This device is a non-invasive nasal mask designed to deliver continuous positive airway pressure or bi-level therapy to pediatric patients requiring ventilation support.
Is this mask intended for single-patient use?
Yes, the device is intended for single-patient use. This ensures hygiene and prevents cross-contamination, as the mask is designed to be used by one individual in both home and institutional environments.
What is the regulatory status of this device?
The SleepWeaver Advance Pediatric Nasal CPAP Mask is authorized under FDA 510K clearance. It is categorized as a class 2 non-continuous ventilator.
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: SleepWeaver Advance Pediatric - Circadiance, SleepWeaver® Advance - Circadiance, SleepWeaver Product Catalog - Circadiance, CM101325 Pediatric SleepWeaver® Advance CPAP Mask
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151683 | Class II | Active |
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Manufacturer
- Manufacturer
- Circadiance, Llc
Sources (1)
- FDA 510(k) K151683 24 fields · synced Sep 24, 2026