Nanjing Jusha Display Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Nanjing Jusha Display Technology Co., Ltd.” (first 2013, latest 2023), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 58 days. Since 2017 the median was 63 days, against 109 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 | 3 | 115 |
| 2014 | 3 | 39 |
| 2015 | 5 | 32 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 8 | 55 |
| 2020 | 1 | 123 |
| 2021 | 0 | — |
| 2022 | 2 | 158 |
| 2023 | 4 | 58 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nanjing Jusha Display Technology Co., Ltd. took a median 63 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PGY | Display, Diagnostic Radiology | 22 | 22 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
Review panels
- Radiology (25)
- General and Plastic Surgery (1)
Most recent Nanjing Jusha Display Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230728 | JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor | PGY | 2023-06-09 | 85 |
| K231170 | C350/C350G LCD Monitor; M550/M550G LCD Monitor | PGY | 2023-06-07 | 43 |
| K230723 | C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor | PGY | 2023-05-18 | 63 |
| K230643 | CP620G LCD monitor, CP620 LCD monitor | PGY | 2023-05-01 | 54 |
| K222121 | C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor | PGY | 2022-09-19 | 63 |
| K212231 | C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor | PGY | 2022-03-25 | 252 |
| K200742 | JUSHA-CP610 LCD Monitor | PGY | 2020-07-24 | 123 |
| K190831 | E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor | GCJ | 2019-05-31 | 60 |
| K190848 | JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor | PGY | 2019-05-14 | 43 |
| K183496 | JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor | PGY | 2019-04-08 | 112 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nanjing Jusha Display Technology 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.
- Nanjing Bestview Laser S&T Co., Ltd. (5 510(k)s)
- Nanjing Eco Microwave System Co., Ltd. (2 510(k)s)
- Nanjing Jin Bai HE Medical Apparatus Co., Ltd. (2 510(k)s)
- Nanjing Kangni Smart Technology Co., Ltd. (2 510(k)s)
- Nanjing Perlove Medical Equipment Co., Ltd. (2 510(k)s)
- Nanjing Vishee Medical Technology Co., Ltd. (2 510(k)s)
- Nanjing 3h Medical Products Co., Ltd. (1 510(k)s)
- Nanjing CareMoving Rehabilitation Equipment Co.,Ltd (1 510(k)s)
- Nanjing Devin Medical Technology Co., Ltd. (1 510(k)s)
- Nanjing Dewen Medical Technology Co., Ltd. (1 510(k)s)
- Nanjing E-Take Medical Apparatus Co., Ltd. (1 510(k)s)
- Nanjing Jiahe Dental Technology Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nanjing Jusha Display Technology Co., Ltd.?
FDA lists 26 510(k) clearances under the applicant name “Nanjing Jusha Display Technology Co., Ltd.” (first 2013, latest 2023), across 3 product codes in 2 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 Nanjing Jusha Display Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nanjing Jusha Display Technology Co., Ltd. is 58 days. Since 2017: 63 days, versus 109 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nanjing Jusha Display Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are PGY (Display, Diagnostic Radiology, 22); LLZ (System, Image Processing, Radiological, 3); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 26 Nanjing Jusha Display Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code PGY, Nanjing Jusha Display Technology 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.