Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sg 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) |
|---|---|---|---|---|---|
| K230241 | Jumong General | Sg Healthcare Co, Ltd. | 2023-02-23 | 24 | 0 |
| K222080 | Garion Image-Intensified Fluoroscopic X-Ray System, Mobile | Sg Healthcare Co, Ltd. | 2022-10-06 | 83 | 0 |
| K150816 | Jumong Series | Sg Healthcare Co, Ltd. | 2015-05-08 | 42 | 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