Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
SCR — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
161 daysmedian FDA review time
283 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261187 | Hearing Aid Feature | Samsung Electronics Co., Ltd. | 2026-07-31 | 112 | 0 |
| K254044 | Hearing assist | Meta Platform Technologies, LLC | 2026-07-13 | 208 | 0 |
| K251208 | Tuned Self-Fitting Mobile App | Tuned , Ltd. | 2025-09-26 | 161 | 0 |
| K243150 | Nuance Audio Hearing Aid Software | Luxottica Group S.P.A. | 2025-01-31 | 123 | 0 |
| DEN230081 | Hearing Aid Feature (HAF) | Apple, Inc. | 2024-09-12 | 283 | 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