Infinitt Co., Ltd.: FDA clearances and approvals
Infinitt Co., Ltd. has 12 FDA 510(k) clearances (first 2004, latest 2017), across 1 product code in 1 review panel. Median 510(k) review time: 52 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 122 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Infinitt Co., Ltd.'s cleared 510(k)s took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 12 | 12 |
Review panels
- Radiology (12)
Most recent Infinitt Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163290 | INFINITT ULite | LLZ | 2017-03-24 | 122 |
| K111660 | XELIS CARDIAC | LLZ | 2011-09-13 | 91 |
| K111613 | XELIS FUSION | LLZ | 2011-09-08 | 91 |
| K103130 | XELIS 3D | LLZ | 2011-07-28 | 279 |
| K102684 | XELIS DENTAL | LLZ | 2010-10-01 | 14 |
| K082990 | INFINITT XELIS | LLZ | 2008-11-20 | 44 |
| K082706 | INFINITT CARDIOLOGY PACS | LLZ | 2008-11-06 | 51 |
| K052545 | INFINITT G3 PACS | LLZ | 2005-11-08 | 54 |
| K052284 | REFORMAT GATEWAY | LLZ | 2005-10-17 | 56 |
| K051715 | STARPACS DENTAL | LLZ | 2005-08-02 | 36 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Infinitt Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Infinitt Co., Ltd. have?
Infinitt Co., Ltd. has 12 FDA 510(k) clearances (first 2004, latest 2017), across 1 product code in 1 review panel.
How long does FDA take to clear Infinitt Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Infinitt Co., Ltd.'s cleared 510(k)s is 52 days.
What devices does Infinitt Co., Ltd. make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 12).
Has Infinitt Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Infinitt Co., Ltd. Related entities may recall under other names.
Next steps
- See all 12 Infinitt Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Infinitt Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.