Earflo (EF001)
FDA 510(k) clearance K252751 · decided 2026-02-10
Clearance details
- K-number
- K252751
- Device name
- Earflo (EF001)
- Applicant
- Earflo, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-08-29
- Decision date
- 2026-02-10
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- MJV
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- San Carlos, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Earflo
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ear Pressure Relief Device(Model:ER813B) (K230502) | Ningbo Albert Novosino Co., Ltd. | 2023-06-09 |
| Eustachi Ear Pressure Relief Device (K203754) | Exercore, LLC | 2021-02-19 |
| EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 (K073401) | Micromedics, Inc. | 2008-03-14 |
| EARCLEAR (K951596) | Arisil Medical | 1995-05-24 |
| OTOVENT (K920840) | Abigo Medical AB | 1992-10-05 |
Recalls involving this device
No recalls on record reference this clearance.