Ankon Technologies Co., Ltd.: FDA clearances and approvals
Ankon Technologies Co., Ltd. has 1 FDA 510(k) clearance (first 2022, latest 2022), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time: 183 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 183 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Ankon Technologies Co., Ltd.'s cleared 510(k)s took a median 183 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | 1 | 1 |
| QZF | Gastrointestinal Capsule Endoscopy Analysis Software Device | 1 | 0 |
Review panels
Most recent Ankon Technologies Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221590 | NaviCam Small Bowel Capsule Endoscopy System | NEZ | 2022-12-02 | 183 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230027 | De Novo | Gastrointestinal Capsule Endoscopy Analysis Software Device | 2023-12-12 |
Recalls
openFDA lists no recalls under a recalling firm named Ankon Technologies 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 Ankon Technologies Co., Ltd. have?
Ankon Technologies Co., Ltd. has 1 FDA 510(k) clearance (first 2022, latest 2022), plus 1 De Novo decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Ankon Technologies Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Ankon Technologies Co., Ltd.'s cleared 510(k)s is 183 days.
What devices does Ankon Technologies Co., Ltd. make?
Its most frequent FDA product codes are NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule, 1); QZF (Gastrointestinal Capsule Endoscopy Analysis Software Device, 1).
Has Ankon Technologies Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ankon Technologies Co., Ltd. Related entities may recall under other names.
Next steps
- See all 1 Ankon Technologies Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NEZ, Ankon Technologies 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.