510(k) K250122
K250122 is an FDA 510(k) premarket notification submitted by Splintek, Inc. for the device "SleepRight Snore Aid". The FDA issued a decision of Substantially Equivalent on May 19, 2025. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Splintek, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 2025
- Date Received
- January 17, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Anti-Snoring
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type