ShaeferH
FDA 510(k) clearance K252942 · decided 2026-04-10
Clearance details
- K-number
- K252942
- Device name
- ShaeferH
- Applicant
- Shaeferh, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-09-15
- Decision date
- 2026-04-10
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- LRK
- Device class
- 2
- Regulation number
- 872.5570
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| SnØreNegatØr (K261912) | DnB Innovations, LLC | 2026-07-31 |
| Virtus (K261366) | Somnomed, Inc. | 2026-06-12 |
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| Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) (K253845) | Ram.Shaw Pte. , Ltd. | 2026-03-03 |
| Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) (K252531) | Myofunctional Research Co. | 2026-03-02 |
| Park Dental Nylon MAD (K252976) | Park Dental Research Corp. | 2025-12-18 |
| QuietLab Pro (K253868) | QuietLab, LLC | 2025-12-05 |
| Hushd Avera (K252161) | Good Sleep CO Pte , Ltd. | 2025-11-25 |
| AIO Breathe (K252525) | Aiomega, LLC | 2025-11-06 |
| NightGuard Aire Max (K252698) | Nightguard Express, LLC | 2025-11-03 |
| Difiney Advanced Anti Snoring Device 4.0 (K253355) | Fissiontech, LLC | 2025-10-29 |
Recalls involving this device
No recalls on record reference this clearance.