Ray Co., Ltd.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Ray Co., Ltd.” (first 2013, latest 2026), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 78 days. Since 2017 the median was 56 days, against 115 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 |
|---|---|---|
| 2013 | 4 | 156 |
| 2014 | 0 | — |
| 2015 | 3 | 262 |
| 2016 | 2 | 70 |
| 2017 | 0 | — |
| 2018 | 3 | 56 |
| 2019 | 2 | 26 |
| 2020 | 0 | — |
| 2021 | 2 | 48 |
| 2022 | 0 | — |
| 2023 | 2 | 28 |
| 2024 | 2 | 222 |
| 2025 | 3 | 83 |
| 2026 | 1 | 56 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ray Co., Ltd. took a median 56 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | 15 | 15 |
| MUH | System, X-Ray, Extraoral Source, Digital | 5 | 5 |
| FXX | Mask, Surgical | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 1 | 1 |
| PNN | Orthodontic Software | 1 | 1 |
Review panels
- Radiology (22)
- Dental (1)
- General Hospital (1)
Most recent Ray Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260462 | RCT800 | OAS | 2026-04-09 | 56 |
| K251798 | RCT700 | OAS | 2025-11-25 | 166 |
| K251109 | SMARTDent | LLZ | 2025-05-21 | 40 |
| K243903 | RCT600 | OAS | 2025-03-12 | 83 |
| K233625 | RAYDENT SW | PNN | 2024-05-16 | 185 |
| K232325 | RAYSCAN a-Expert | MUH | 2024-04-18 | 259 |
| K232287 | RAYSCAN a-Expert3D | OAS | 2023-08-31 | 30 |
| K230753 | RCT800 | OAS | 2023-04-11 | 25 |
| K213226 | RCT700 | OAS | 2021-11-29 | 61 |
| K211105 | Ear-Friendly Mask | FXX | 2021-05-17 | 34 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ray 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ray Co., Ltd.?
FDA lists 24 510(k) clearances under the applicant name “Ray Co., Ltd.” (first 2013, latest 2026), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ray Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ray Co., Ltd. is 78 days. Since 2017: 56 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ray Co., Ltd.?
The most frequent FDA product codes under this applicant name are OAS (X-Ray, Tomography, Computed, Dental, 15); MUH (System, X-Ray, Extraoral Source, Digital, 5); FXX (Mask, Surgical, 1).
Next steps
- See all 24 Ray Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OAS, Ray 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.