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. Most products in this code are oral appliances that hold the lower jaw forward during sleep. 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). LRK has a large pool of predicates, and single-product filings from small companies are common in it.
Clearance details
- Applicant
- Shaeferh, LLC
- Product code
- 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.