ShaeferH— 510(k) K252942
Substantially EquivalentShaeferh, LLC
FDA 510(k) clearance K252942 for ShaeferH, Substantially Equivalent on 2026-04-10. Applicant: Shaeferh, LLC. Device class: 2.
Summary
ShaeferH is filed under LRK, anti-snoring devices. The device name is just the company name, and the record doesn't describe the design.
Class II, 21 CFR 872.5570. The Dental panel reviewed it as a Traditional 510(k).
Shaeferh, LLC filed from Boston, Massachusetts. Review took 207 days (September 15, 2025 to April 10, 2026).
Clearance details
- Applicant
- Shaeferh, 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
- Boston, MA, 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.