SnØreNegatØr— 510(k) K261912
Substantially EquivalentDnB Innovations, LLC
FDA 510(k) clearance K261912 for SnØreNegatØr, Substantially Equivalent on 2026-07-31. Applicant: DnB Innovations, LLC. Device class: 2.
Summary
SnØreNegatØr from DnB Innovations is filed under LRK, anti-snoring devices. The record doesn't describe its design or materials.
Class II, 21 CFR 872.5570. Dental is both the classification panel and the review panel, and it was a Traditional 510(k).
DnB Innovations filed from Keller, Texas. The decision came 53 calendar days after receipt (June 8 to July 31, 2026).
Clearance details
- Applicant
- DnB Innovations, LLC
- Product code
- Product code LRK
- Device class
- Class 2
- Regulation
- 21 CFR 872.5570
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Keller, TX, US
Recent devices under product code LRK
view allAdverse events under product code LRK
product code LRK- Injury
- 246
- Malfunction
- 1,044
- Total
- 1,290
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.