Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QDD · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
147 daysmedian FDA review time
292 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223911 | Lumen 155-SF | Intricon Corporation | 2023-10-17 | 292 | 0 |
| K220403 | Vibe SF Self-Fitting Hearing Aid | Wsaud A/S | 2022-08-12 | 182 | 0 |
| K220303 | MDHearingAid app, MDHearingAid Smart hearing aids | Mdhearingaid | 2022-08-04 | 183 | 0 |
| K213424 | Jabra Enhance Plus | GN Hearing A/S | 2022-01-19 | 90 | 0 |
| K212609 | BHA100 Series Braun Clear Hearing Aid | Kaz USA, Inc., A Helen of Troy Company | 2022-01-05 | 141 | 0 |
| K211008 | Bose SoundControl Hearing Aids | Bose Corporation | 2021-05-05 | 30 | 0 |
| DEN180026 | Bose Hearing Aid | Bose Corporation | 2018-10-05 | 147 | 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