Guangdong Genial Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Guangdong Genial Technology Co., Ltd.” (first 2023, latest 2024), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 205 days. Since 2017 the median was 205 days, against 189 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 |
|---|---|---|
| 2023 | 3 | 205 |
| 2024 | 2 | 210 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Guangdong Genial Technology Co., Ltd. took a median 205 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 189 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
Review panels
- Cardiovascular (2)
- General Hospital (2)
- Anesthesiology (1)
Most recent Guangdong Genial Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240333 | Wearable Digital Thermometer (T31) | FLL | 2024-10-30 | 268 |
| K232678 | Digital Thermometer, Model T28, T28L | FLL | 2024-01-31 | 152 |
| K231250 | Digital Blood Pressure Monitor | DXN | 2023-11-28 | 211 |
| K231245 | Digital Blood Pressure Monitor (Arm Type) | DXN | 2023-11-22 | 205 |
| K231243 | Finger Clip Pulse Oximeter | DQA | 2023-10-31 | 183 |
Recalls
openFDA lists no recalls under a recalling firm named Guangdong Genial 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.
- Guangdong Biolight Meditech Co., Ltd. (21 510(k)s)
- Guangdong Transtek Medical Electronics Co., Ltd. (17 510(k)s)
- Guangdong Kingfa Sci. & Tech.Co., Ltd. (14 510(k)s)
- Guangdong Optomedic Technologies, Inc. (9 510(k)s)
- Guangdong Horigen Mother & Baby Products Co., Ltd. (7 510(k)s)
- Guangdong Newdermo Biotech Co., Ltd. (5 510(k)s)
- Guangdong Prestige Technology Co., Ltd. (5 510(k)s)
- Guangdong Jinme Medical Technology Co., Ltd. (4 510(k)s)
- Guangdong Youmeng Electrical Technology Co., Ltd. (4 510(k)s)
- Guangdong Gymda Medical Technology Co.,Ltd (2 510(k)s)
- Guangdong Kaiyang Medical Technology Co., Ltd. (2 510(k)s)
- Guangdong Xinyu Electronic and Technology Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Guangdong Genial Technology Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Guangdong Genial Technology Co., Ltd.” (first 2023, latest 2024), across 3 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 Guangdong Genial Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guangdong Genial Technology Co., Ltd. is 205 days. Since 2017: 205 days, versus 189 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Guangdong Genial Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2); FLL (Continuous Measurement Thermometer, 2); DQA (Oximeter, 1).
Next steps
- See all 5 Guangdong Genial Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Guangdong Genial 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.