Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Y & J Bio Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
153 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223278 | easy Claire | Y & J Bio Co., Ltd. | 2022-11-17 | 24 | 0 |
| K213285 | easy Claire | Y & J Bio Co., Ltd. | 2022-03-03 | 153 | 0 |
| K202983 | easy Hairfull | Y & J Bio Co., Ltd. | 2020-12-08 | 69 | 0 |
| K180617 | Hair Up | Y & J Bio Co., Ltd. | 2018-06-01 | 85 | 0 |
| K172968 | Hair Up | Y & J Bio Co., Ltd. | 2018-01-05 | 101 | 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