Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gemss Medical Systems Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163140 | SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System | Gemss Medical Systems Co., Ltd. | 2017-05-26 | 198 | 0 |
| K160065 | GEMSS Medical System Surgical Mobile Fluoroscopic X-ray Syst | Gemss Medical Systems Co., Ltd. | 2016-05-20 | 128 | 0 |
| K133695 | TITAN 11 | Gemss Medical Systems Co., Ltd. | 2014-08-07 | 247 | 0 |
| K132289 | GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYS | Gemss Medical Systems Co., Ltd. | 2014-06-16 | 328 | 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