ProSomnus RPMO2 OSA Device (RPMO2 OSA)
Summary
Prosomnus Sleep Technologies received 510(k) clearance for ProSomnus RPMO2 OSA Device (RPMO2 OSA), a PLC device. Cleared on 2026-04-06.
Details
Source
510(k) Clearance
External ID
K252765
Action Date
2026-04-06
Status
Traditional
Category
device
Product Code
PLC
Product Description
ProSomnus RPMO2 OSA Device (RPMO2 OSA). Product code: PLC.
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. Prosomnus Sleep Technologies has received 2 total clearances in our database.
Prosomnus Sleep Technologies has 2 FDA actions in our database, including 2 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 Prosomnus Sleep Technologies have FDA actions?
Prosomnus Sleep Technologies has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K252765" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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