VATECH Co., Ltd.: FDA filings under this applicant name
FDA lists 40 510(k) clearances under the applicant name “VATECH Co., Ltd.” (first 2008, latest 2026), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 102 days. Since 2017 the median was 48 days, against 106 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 |
|---|---|---|
| 2012 | 6 | 40 |
| 2013 | 2 | 116 |
| 2014 | 1 | 318 |
| 2015 | 1 | 86 |
| 2016 | 3 | 139 |
| 2017 | 3 | 26 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 76 |
| 2021 | 3 | 28 |
| 2022 | 2 | 66 |
| 2023 | 1 | 29 |
| 2024 | 1 | 294 |
| 2025 | 2 | 140 |
| 2026 | 1 | 77 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name VATECH Co., Ltd. took a median 48 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | 19 | 19 |
| MUH | System, X-Ray, Extraoral Source, Digital | 8 | 8 |
| EHD | Unit, X-Ray, Extraoral With Timer | 6 | 6 |
| IZL | System, X-Ray, Mobile | 2 | 2 |
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 1 | 1 |
Review panels
- Radiology (40)
Most recent VATECH Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | OAS | 2026-03-31 | 77 |
| K243088 | Green X 12 SE (PHT-40CHS) | OAS | 2025-02-21 | 144 |
| K243081 | Green X 21 (PHT-90CHO) | OAS | 2025-02-14 | 137 |
| K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) | MUH | 2024-10-25 | 294 |
| K231796 | Grreen X 12 (Model: PHT-75CHS) | OAS | 2023-07-19 | 29 |
| K223058 | EzRay Air 2 Wall (Model: VEX-S350W) | EHD | 2022-10-26 | 26 |
| K213462 | EzRay M18 (Model: VMX-P400) | IZL | 2022-02-11 | 107 |
| K210329 | Green X 18(Model : PHT-75CHS) | OAS | 2021-02-18 | 14 |
| K203667 | EzRay M (Model: VMX-P300) | IZL | 2021-02-02 | 48 |
| K203797 | vatech A9 (Model : PHT-30CSS) | OAS | 2021-01-25 | 28 |
30 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named VATECH 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.
- Vatech Acucera, Inc. (4 510(k)s)
- Vatech Mcis Co., Ltd. (1 510(k)s)
- Vatech Value Added Technology Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under VATECH Co., Ltd.?
FDA lists 40 510(k) clearances under the applicant name “VATECH Co., Ltd.” (first 2008, latest 2026), across 8 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 VATECH Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name VATECH Co., Ltd. is 102 days. Since 2017: 48 days, versus 106 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under VATECH Co., Ltd.?
The most frequent FDA product codes under this applicant name are OAS (X-Ray, Tomography, Computed, Dental, 19); MUH (System, X-Ray, Extraoral Source, Digital, 8); EHD (Unit, X-Ray, Extraoral With Timer, 6).
Next steps
- See all 40 VATECH Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OAS, VATECH 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.