Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QPF — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
155 daysmedian FDA review time
211 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253442 | EarliPoint Assessment | Earlitec Diagnostics | 2026-03-05 | 155 | 0 |
| K243558 | Canvas Dx | Cognoa, Inc. | 2025-04-11 | 144 | 0 |
| K243891 | EarliPoint System | Earlitec Diagnostics | 2025-03-26 | 98 | 0 |
| K230337 | EarliPoint | Earlitec Diagnostics, Inc. | 2023-06-29 | 142 | 0 |
| K213882 | EarliPoint System | Earlitec Diagnostics, Inc. | 2022-06-08 | 177 | 0 |
| DEN200069 | Cognoa ASD Diagnosis Aid | Cognoa, Inc. | 2021-06-02 | 211 | 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