Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
Summary
Sleepnet Corporation received 510(k) clearance for Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask, a BZD device. Cleared on 2026-01-15.
Details
Source
510(k) Clearance
External ID
K251847
Action Date
2026-01-15
Status
Traditional
Category
device
Product Code
BZD
Product Description
Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask. Product code: BZD.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Sleepnet Corporation has received 7 total clearances in our database.
Sleepnet Corporation has 14 FDA actions in our database, including 7 recalls and 7 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Sleepnet Corporation have FDA actions?
Sleepnet Corporation has 14 FDA actions in our database, including 7 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K251847" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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