K252751 is an FDA 510(k) clearance for the Earflo (EF001). This device is classified as a Device, Inflation, Middle Ear.
Submitted by Earflo, Inc. (San Carlos, US). The FDA issued a Cleared decision on February 10, 2026, 165 days after receiving the submission on August 29, 2025.
This device falls under the Ear, Nose, Throat FDA review panel.
| 510(k) Number | K252751 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2025 |
| Decision Date | February 10, 2026 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | MJV - Device, Inflation, Middle Ear |
| Device Class | - |