Shenzhen Beacon Display Technology Co., Ltd.: FDA clearances and approvals
Shenzhen Beacon Display Technology Co., Ltd. has 17 FDA 510(k) clearances (first 2013, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time: 48 days. Since 2017 its median was 57 days, against 115 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 15 |
| 2014 | 2 | 30 |
| 2015 | 0 | — |
| 2016 | 1 | 21 |
| 2017 | 1 | 39 |
| 2018 | 1 | 89 |
| 2019 | 0 | — |
| 2020 | 4 | 54 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 129 |
| 2024 | 4 | 56 |
| 2025 | 2 | 69 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Shenzhen Beacon Display Technology Co., Ltd.'s cleared 510(k)s took a median 57 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 |
|---|---|---|---|
| PGY | Display, Diagnostic Radiology | 13 | 13 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| PZZ | Digital Pathology Display | 1 | 1 |
Review panels
Most recent Shenzhen Beacon Display Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252780 | LCD Monitor (CL1902A, CL2103F) | PGY | 2025-12-19 | 108 |
| K253242 | LCD Monitor (C1216W, C822W, C821W) | PGY | 2025-10-29 | 30 |
| K233119 | 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T | PZZ | 2024-12-28 | 458 |
| K243031 | LCD Monitors C310S, G310S, C316S, G316S, C616W | PGY | 2024-10-25 | 28 |
| K240310 | LCD Monitors C310S, G310S, C316S, G316S, C616W | PGY | 2024-03-29 | 56 |
| K233897 | 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S) | PGY | 2024-02-06 | 57 |
| K231026 | 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) | PGY | 2023-08-18 | 129 |
| K202374 | 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+ | PGY | 2020-10-19 | 61 |
| K201211 | 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+ | PGY | 2020-09-03 | 121 |
| K201599 | 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ | PGY | 2020-07-02 | 20 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen Beacon Display Technology 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 Shenzhen Beacon Display Technology Co., Ltd. have?
Shenzhen Beacon Display Technology Co., Ltd. has 17 FDA 510(k) clearances (first 2013, latest 2025), across 3 product codes in 2 review panels.
How long does FDA take to clear Shenzhen Beacon Display Technology Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Shenzhen Beacon Display Technology Co., Ltd.'s cleared 510(k)s is 48 days. Since 2017: 57 days, versus 115 days for all cleared 510(k)s in the same product codes.
What devices does Shenzhen Beacon Display Technology Co., Ltd. make?
Its most frequent FDA product codes are PGY (Display, Diagnostic Radiology, 13); LLZ (System, Image Processing, Radiological, 3); PZZ (Digital Pathology Display, 1).
Has Shenzhen Beacon Display Technology Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Shenzhen Beacon Display Technology Co., Ltd. Related entities may recall under other names.
Next steps
- See all 17 Shenzhen Beacon Display Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code PGY, Shenzhen Beacon Display Technology 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.