Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MJV — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
105 daysmedian FDA review time
224 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252751 | Earflo (EF001) | Earflo, Inc. | 2026-02-10 | 165 | 0 |
| K230502 | Ear Pressure Relief Device(Model:ER813B) | Ningbo Albert Novosino Co., Ltd. | 2023-06-09 | 105 | 0 |
| K203754 | Eustachi Ear Pressure Relief Device | Exercore, LLC | 2021-02-19 | 58 | 0 |
| K073401 | EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 | Micromedics, Inc. | 2008-03-14 | 101 | 0 |
| K951596 | EARCLEAR | Arisil Medical | 1995-05-24 | 47 | 0 |
| K920840 | OTOVENT | Abigo Medical AB | 1992-10-05 | 224 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda