Silenzio Delta Continuous Positive Airway Pressure System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K980551 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 Silenzio Delta Continuous Positive Airway Pressure System is a ventilator for non-continuous use, classified as a Class II medical device. It delivers continuous positive airway pressure (CPAP) to maintain open airways in patients, primarily for the management of obstructive sleep apnea (OSA) in adults weighing 30 kg or more. The device operates in multiple modes, including CPAP and bi-level positive airway pressure (BPAP), to provide adjustable pressure support during inhalation and exhalation.
This system is intended for use in clinical and home settings, supplied as a reusable medical device. It adheres to FDA regulatory standards, having received 510(k) clearance under the Anesthesiology advisory committee. The device is designed for single-patient use per session, with no explicit indication of MRI compatibility. Storage and maintenance instructions are manufacturer-specific, and compliance with FDA regulation number 868.5905 applies. Authorisation details include FDA clearance (K980551) and registration numbers for tracking.
Frequently asked questions
What is the Silenzio Delta CPAP System used for?
The Silenzio Delta Continuous Positive Airway Pressure System is designed to maintain open airways in patients by delivering continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP). It is primarily intended for managing obstructive sleep apnea (OSA) in adults weighing 30 kg or more. The device provides adjustable pressure support during inhalation and exhalation, making it suitable for both clinical and home use.
Is the Silenzio Delta CPAP System reusable or single-use?
The Silenzio Delta is classified as a reusable medical device. It is intended for single-patient use per session, but the device itself is not disposable. Maintenance and cleaning instructions are provided by the manufacturer to ensure proper reuse.
What regulatory approval does the Silenzio Delta CPAP System hold?
The Silenzio Delta Continuous Positive Airway Pressure System has received FDA 510(k) clearance under the Anesthesiology advisory committee. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and adheres to FDA regulatory standards, specifically regulation number 868.5905.
What modes of operation does the Silenzio Delta CPAP System support?
The Silenzio Delta operates in multiple modes, including CPAP (Continuous Positive Airway Pressure) and BPAP (Bi-Level Positive Airway Pressure). CPAP delivers a single, constant pressure to keep airways open, while BPAP provides adjustable pressure support during inhalation and exhalation, accommodating varying patient needs.
How should the Silenzio Delta CPAP System be stored?
Storage instructions for the Silenzio Delta are manufacturer-specific and should be followed closely to maintain device performance and hygiene. Since it is a reusable device, proper cleaning and maintenance protocols are essential to prevent contamination and ensure reliable operation. Always refer to the manufacturer’s guidelines for detailed storage and care instructions.
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: Silenzio Delta Continuous Positive Airway Pressure System, Silenzio CPAP System Overview | PDF | Sleep Apnea | Nature, Silenzio Delta Continuous Positive Airway Pressure System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K980551 | Class II | Active |
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Manufacturer
- Manufacturer
- Nidek Medical Products Inc.
- FDA Applicant
- Nidek Medical Products, Inc.
Sources (1)
- FDA 510(k) K980551 24 fields · synced Oct 6, 2026