Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DeepHealth, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
196 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253825 | Saige-Dx | DeepHealth, Inc. | 2026-06-15 | 196 | 0 |
| K254131 | BAC | DeepHealth, Inc. | 2026-05-21 | 150 | 0 |
| K251873 | Saige-Dx | DeepHealth, Inc. | 2025-08-11 | 54 | 0 |
| K243703 | TechLive | DeepHealth, Inc. | 2025-06-05 | 188 | 0 |
| K243705 | Saige-Density (2.5.0) | DeepHealth, Inc. | 2024-12-19 | 20 | 0 |
| K243688 | Saige-Dx (3.1.0) | DeepHealth, Inc. | 2024-12-19 | 20 | 0 |
| K241747 | Saige-Dx | DeepHealth, Inc. | 2024-11-18 | 153 | 0 |
| K222275 | Saige-Density | DeepHealth, Inc. | 2022-12-16 | 140 | 0 |
| K220105 | Saige-Dx | DeepHealth, Inc. | 2022-05-12 | 120 | 0 |
| K203517 | Saige-Q | DeepHealth, Inc. | 2021-04-16 | 137 | 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