Devilbiss Smartlink Ii System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140880 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 DEVILBISS SMARTLINK II SYSTEM is a non-continuous ventilator (respirator) designed for use in conjunction with DeVilbiss DV51, DV53, DV54, DV55, DV56, and DV57 Series CPAP Systems. It is indicated for the follow-up of obstructive sleep apnea in patients weighing above 30 kg who are on nasal CPAP therapy. The system functions as a monitoring and data collection tool to support clinical management of sleep apnea in home and healthcare settings.
The device is intended for use in home and healthcare environments and is classified under the Anesthesiology medical specialty. It is regulated under product code BZD and regulation number 868.5905. The system is cleared through the FDA 510(k) process under number K140880, with a decision of Substantially Equivalent. No information on sterility, reusability, MRI safety, or specific storage conditions is provided in the available data.
Frequently asked questions
What is the DeVilbiss SmartLink II System used for?
It is a non-continuous ventilator and data collection tool designed to monitor and support the clinical management of obstructive sleep apnea in patients weighing more than 30 kg who are using nasal CPAP therapy. It works in conjunction with specific DeVilbiss CPAP systems.
Which DeVilbiss CPAP systems is it compatible with?
The system is specifically designed for use with the DeVilbiss DV51, DV53, DV54, DV55, DV56, and DV57 Series CPAP Systems.
Where is this device intended to be used?
The device is intended for use in both home and healthcare settings to support ongoing monitoring and data collection for sleep apnea management.
What is the regulatory classification of this device?
It is classified as a Class II medical device under the Anesthesiology specialty, regulated under product code BZD and regulation number 868.5905. It was cleared through the FDA 510(k) process.
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: DEVILBISS SMARTLINK II SYSTEM 510 (k) K140880 - FDA.report, Medical Aids - Drive Medical, DEVILBISS SMARTLINK II SYSTEM (K140880) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140880 | Class II | Active |
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Manufacturer
- Manufacturer
- Devilbiss Healthcare Llc
- FDA Applicant
- Devilbiss Healthcare, LLC
Sources (1)
- FDA 510(k) K140880 24 fields · synced Sep 26, 2026