Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Infinitt Healthcare 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) |
|---|---|---|---|---|---|
| K243449 | INFINITT DPS | Infinitt Healthcare Co., Ltd. | 2025-12-09 | 397 | 0 |
| K193369 | Xelis Dental 2.0 | Infinitt Healthcare Co., Ltd. | 2020-04-14 | 131 | 0 |
| K193498 | Infinitt RT PACS | Infinitt Healthcare Co., Ltd. | 2020-02-13 | 58 | 0 |
| K172803 | Infinitt PACS 7.0 | Infinitt Healthcare Co., Ltd. | 2017-10-27 | 39 | 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