Ever Fortune.Ai, Co., Ltd.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Ever Fortune.Ai, Co., Ltd.” (first 2021, latest 2026), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 158 days. Since 2017 the median was 158 days, against 125 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 137 |
| 2022 | 5 | 161 |
| 2023 | 3 | 87 |
| 2024 | 3 | 158 |
| 2025 | 1 | 155 |
| 2026 | 2 | 242 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ever Fortune.Ai, Co., Ltd. took a median 158 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | 5 | 5 |
| QKB | Radiological Image Processing Software For Radiation Therapy | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | 2 | 2 |
| QIH | Automated Radiological Image Processing Software | 2 | 2 |
| KPS | System, Tomography, Computed, Emission | 1 | 1 |
Review panels
- Radiology (15)
Most recent Ever Fortune.Ai, Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253163 | EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) | QAS | 2026-04-22 | 208 |
| K251306 | Seg Pro V3 (RT-300) | QKB | 2026-01-28 | 275 |
| K242821 | EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) | QAS | 2025-02-20 | 155 |
| K241923 | EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) | QAS | 2024-12-06 | 158 |
| K234042 | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) | QIH | 2024-06-07 | 169 |
| K240291 | EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM | QAS | 2024-04-08 | 67 |
| K231025 | EFAI NeuroSuite CT ICH Assessment System | QAS | 2023-10-04 | 176 |
| K231928 | EFAI RTSUITE CT HCAP-Segmentation System | QKB | 2023-09-25 | 87 |
| K232100 | Efai Pacs Picture Archiving and Communication System Pro | LLZ | 2023-08-08 | 25 |
| K221552 | EFAI ChestSuite XR Pneumothorax Assessment System | QFM | 2022-11-08 | 161 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ever Fortune.Ai, Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ever Light Plastic Products Co., Ltd. (11 510(k)s)
- Ever Global (Vietnam) Enterprise Corporation (8 510(k)s)
- Ever Growth (Vietnam) Co. , Ltd. (4 510(k)s)
- Ever Global Enterprise Corporation (2 510(k)s)
- Ever Prosperous Instrument, Inc. (2 510(k)s)
- Ever Surplus (Usa), Inc. (2 510(k)s)
- Ever Glory Intl., Inc. (1 510(k)s)
- Ever Great International , Ltd. (1 510(k)s)
- Ever Growing Ent. Co., Ltd. (1 510(k)s)
- Ever Growth (Vietnam) Corporation Limited (1 510(k)s)
- Ever Prime Enterprises , Ltd. (1 510(k)s)
- Ever Scientific (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ever Fortune.Ai, Co., Ltd.?
FDA lists 15 510(k) clearances under the applicant name “Ever Fortune.Ai, Co., Ltd.” (first 2021, latest 2026), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ever Fortune.Ai, Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ever Fortune.Ai, Co., Ltd. is 158 days. Since 2017: 158 days, versus 125 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ever Fortune.Ai, Co., Ltd.?
The most frequent FDA product codes under this applicant name are QAS (Radiological Computer-Assisted Triage And Notification Software, 5); QKB (Radiological Image Processing Software For Radiation Therapy, 3); LLZ (System, Image Processing, Radiological, 2).
Next steps
- See all 15 Ever Fortune.Ai, Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QAS, Ever Fortune.Ai, Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.