Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GEMSS HEALTHCARE 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) |
|---|---|---|---|---|---|
| K260236 | XLITE | GEMSS HEALTHCARE CO., LTD. | 2026-08-03 | 189 | 0 |
| K233200 | XPLUS 35 Series (XPLUS 35, XPLUS 35FD) | GEMSS HEALTHCARE CO., LTD. | 2023-11-16 | 49 | 0 |
| K230800 | XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN- | GEMSS HEALTHCARE CO., LTD. | 2023-11-02 | 224 | 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