Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Heuron Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
130 daysmedian FDA review time
613 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233247 | Heuron ICH | Heuron Co., Ltd. | 2024-05-15 | 230 | 0 |
| K231642 | Veuron-Brain-pAb3 | Heuron Co., Ltd. | 2023-10-13 | 130 | 0 |
| K203279 | Veuron-Brain-mN1 | Heuron Co., Ltd. | 2022-07-12 | 613 | 0 |
| K213801 | Veuron-Brain-pAb2 | Heuron Co., Ltd. | 2022-02-04 | 60 | 0 |
| K203142 | Veuron-Brain-pAb | Heuron Co., Ltd. | 2021-01-15 | 87 | 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