Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Truvian Health · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251157 | Core Metabolic | Truvian Health | 2026-01-09 | 269 | 0 |
| K251091 | Lipids | Truvian Health | 2025-12-30 | 264 | 0 |
| K251074 | Tru Liver Health Test Panel | Truvian Health | 2025-12-19 | 255 | 0 |
| K251058 | Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health | 2025-11-26 | 236 | 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