Submission Details
| 510(k) Number | K252751 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Earflo (EF001)
Feb 2026
Decision
165d
Days
—
Risk
About This 510(k) Submission
K252751 is an FDA 510(k) clearance for the Earflo (EF001), 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 review panel.
Device Classification
| Product Code | MJV — Device, Inflation, Middle Ear |
| Device Class | — |
Manufacturer
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