Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Braxx Biotech Co., Ltd. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243045 | “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001 | Braxx Biotech Co., Ltd. | 2024-11-19 | 53 | 0 |
| K183332 | “BRAXX” Esophageal Brachytherapy Applicator | Braxx Biotech Co., Ltd. | 2019-04-16 | 134 | 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