Vinno Technology (Suzhou) Co.,Ltd: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Vinno Technology (Suzhou) Co.,Ltd” (first 2020, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 172 days. Since 2017 the median was 172 days, against 101 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 |
|---|---|---|
| 2020 | 1 | 364 |
| 2021 | 0 | — |
| 2022 | 1 | 174 |
| 2023 | 3 | 170 |
| 2024 | 1 | 280 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vinno Technology (Suzhou) Co.,Ltd took a median 172 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 6 | 6 |
Review panels
- Radiology (6)
Most recent Vinno Technology (Suzhou) Co.,Ltd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240676 | ULTIMUS Series Ultrasound Diagnostic System | IYN | 2024-12-16 | 280 |
| K230160 | VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E | IYN | 2023-06-23 | 155 |
| K223920 | VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P | IYN | 2023-06-17 | 170 |
| K223917 | VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P | IYN | 2023-06-17 | 170 |
| K221911 | VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP | IYN | 2022-12-21 | 174 |
| K190120 | VINNO 8, VINNO 6, VINNO 5 | IYN | 2020-01-23 | 364 |
Recalls
openFDA lists no recalls under a recalling firm named Vinno Technology (Suzhou) 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 Vinno Technology (Suzhou) Co.,Ltd?
FDA lists 6 510(k) clearances under the applicant name “Vinno Technology (Suzhou) Co.,Ltd” (first 2020, latest 2024), across 1 product code 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 Vinno Technology (Suzhou) Co.,Ltd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vinno Technology (Suzhou) Co.,Ltd is 172 days. Since 2017: 172 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vinno Technology (Suzhou) Co.,Ltd?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 6).
Next steps
- See all 6 Vinno Technology (Suzhou) Co.,Ltd clearances with predicates and recalls
- Run predicate analysis for product code IYN, Vinno Technology (Suzhou) 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.