Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hung Chun Bio-S Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172821 | Ti-one 101 TS Dental Implant System | Hung Chun Bio-S Co., Ltd. | 2018-06-11 | 266 | 0 |
| K151362 | HC Spinal System | Hung Chun Bio-S Co., Ltd. | 2016-05-05 | 350 | 0 |
| K110425 | HC-BIOS DENTAL IMPLANT | Hung Chun Bio-S Co., Ltd. | 2012-07-27 | 529 | 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