Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QAT · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
192 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240279 | VIDAS TBI (GFAP, UCH-L1) | bioMerieux, Inc. | 2024-05-01 | 90 | 0 |
| K234143 | i-STAT TBI Cartridge with the i-STAT Alinity System | Abbott Point of Care | 2024-03-27 | 89 | 0 |
| K232669 | TBI | Abbott Laboratories | 2023-09-29 | 28 | 0 |
| K223602 | Traumatic brain injury (TBI) test | Abbott Laboratories | 2023-03-02 | 90 | 0 |
| K201778 | i-STAT TBI Plasma cartridge with the i-STAT Alinity System | Abbott Laboratories | 2021-01-08 | 192 | 0 |
| DEN170045 | Banyan BTI | Banyan Biomarkers, Inc. | 2018-02-14 | 170 | 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