Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Infinitt Co., Ltd. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
54 daysmedian FDA review time
122 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163290 | INFINITT ULite | Infinitt Co., Ltd. | 2017-03-24 | 122 | 0 |
| K111660 | XELIS CARDIAC | Infinitt Co., Ltd. | 2011-09-13 | 91 | 0 |
| K111613 | XELIS FUSION | Infinitt Co., Ltd. | 2011-09-08 | 91 | 0 |
| K103130 | XELIS 3D | Infinitt Co., Ltd. | 2011-07-28 | 279 | 0 |
| K102684 | XELIS DENTAL | Infinitt Co., Ltd. | 2010-10-01 | 14 | 0 |
| K082990 | INFINITT XELIS | Infinitt Co., Ltd. | 2008-11-20 | 44 | 0 |
| K082706 | INFINITT CARDIOLOGY PACS | Infinitt Co., Ltd. | 2008-11-06 | 51 | 0 |
| K052545 | INFINITT G3 PACS | Infinitt Co., Ltd. | 2005-11-08 | 54 | 0 |
| K052284 | REFORMAT GATEWAY | Infinitt Co., Ltd. | 2005-10-17 | 56 | 0 |
| K051715 | STARPACS DENTAL | Infinitt Co., Ltd. | 2005-08-02 | 36 | 0 |
| K041761 | RAPIDIACOLON | Infinitt Co., Ltd. | 2004-07-13 | 13 | 0 |
| K041500 | STARPACS ORTHOPEDICS SYSTEM | Infinitt Co., Ltd. | 2004-06-21 | 14 | 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