Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
QEB · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
265 daysmedian FDA review time
447 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250464 | Enlight 2100 (TPL-E2103-0) | Timpel S.A. | 2025-09-10 | 204 | 0 |
| K243765 | LuMon(TM) System | Sentec AG | 2025-08-07 | 244 | 0 |
| K222466 | AirTom | Bilab | 2023-06-30 | 318 | 0 |
| K222897 | Enlight 2100 | Timpel S.A. | 2023-03-07 | 165 | 0 |
| K211135 | Enlight 2100 | Timpel S.A. | 2022-01-06 | 265 | 0 |
| DEN170072 | Enlight 1810 | Timpel, Inc. | 2018-12-20 | 447 | 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