Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
QUH — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
188 daysmedian FDA review time
532 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | GN Hearing A/S | 2026-06-25 | 188 | 0 |
| K233747 | Concha Sol Hearing Aids (CL-1001) | Concha Labs | 2024-03-15 | 114 | 0 |
| K233464 | WSA Self-Fitting Hearing Aid Gen 2 | Wsaud A/S | 2024-02-09 | 109 | 0 |
| K231550 | Sontro® OTC Hearing Aids (AI) | Soundwave Hearing, LLC | 2023-10-26 | 149 | 0 |
| K221052 | Self-Fitting hearing aids | Huizhou Jinghao Medical Technology Co., Ltd. | 2023-09-25 | 532 | 0 |
| K223848 | Intrisound™ Tuned Lumen® 155 Hearing Aids | Tuned , Ltd. | 2023-09-08 | 260 | 0 |
| K230538 | All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hea | Sonova AG | 2023-06-16 | 109 | 0 |
| K223137 | Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Applica | Hearx SA (Pty) , Ltd. | 2023-03-14 | 161 | 0 |
| K221698 | Eargo 5 , Eargo 6 | Eargo, Inc. | 2022-12-21 | 191 | 0 |
| K221064 | Nuheara IQbuds 2 PRO Hearing Aid | Nuheara Limited | 2022-10-30 | 202 | 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