Hunan Vathin Medical Instrument Co., Ltd.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Hunan Vathin Medical Instrument Co., Ltd.” (first 2020, latest 2025), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 144 days. Since 2017 the median was 144 days, against 146 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 | 220 |
| 2021 | 0 | — |
| 2022 | 3 | 170 |
| 2023 | 3 | 113 |
| 2024 | 5 | 146 |
| 2025 | 5 | 121 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hunan Vathin Medical Instrument Co., Ltd. took a median 144 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 146 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 6 | 6 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 5 | 5 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | 2 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 2 | 2 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 2 | 2 |
Review panels
Most recent Hunan Vathin Medical Instrument Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250232 | Vathin® Video Bronchoscope System | EOQ | 2025-07-25 | 179 |
| K251599 | Single-use Ureteral Access Sheath | FED | 2025-07-03 | 37 |
| K250785 | Single-use Flexible Ureteroscope | FGB | 2025-05-06 | 53 |
| K243117 | Digital Video Processor | FGB | 2025-01-29 | 121 |
| K242416 | Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL | EOQ | 2025-01-16 | 154 |
| K242535 | Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2) | FAJ | 2024-12-18 | 114 |
| K241612 | Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2) | EOQ | 2024-10-29 | 146 |
| K240167 | Single-use Ureteral Access Sheath | FED | 2024-10-08 | 260 |
| K241434 | Video Ureteroscope System | FGB | 2024-10-04 | 136 |
| K231135 | Video Ureteroscope System | FGB | 2024-01-17 | 271 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hunan Vathin Medical Instrument 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.
- Hunan Accurate Bio-Medical Technology Co., Ltd. (6 510(k)s)
- Hunan Endoso Life Technology Co., Ltd. (3 510(k)s)
- Hunan Eexi Technology & Service Co., Ltd. (2 510(k)s)
- Hunan Guangye Biotechnology Co., Ltd. (2 510(k)s)
- Hunan Handlike Minimally Invasive Surgery Co., Ltd. (2 510(k)s)
- Hunan Heng Chang Pharmaceutical Co., Ltd. (2 510(k)s)
- Hunan Qinghao Puzhong Technology Co., Ltd. (2 510(k)s)
- Hunan Vsmile Biotechnology Co., Ltd. (2 510(k)s)
- Hunan Zhenheyikang Medical Instrument Co., Ltd. (2 510(k)s)
- Hunan Ceramaster Material Technology Co., Ltd. (1 510(k)s)
- Hunan Chopard Medical Devices Co., Ltd. (1 510(k)s)
- Hunan Haipuming Technology Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hunan Vathin Medical Instrument Co., Ltd.?
FDA lists 17 510(k) clearances under the applicant name “Hunan Vathin Medical Instrument Co., Ltd.” (first 2020, latest 2025), across 5 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 Hunan Vathin Medical Instrument Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hunan Vathin Medical Instrument Co., Ltd. is 144 days. Since 2017: 144 days, versus 146 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hunan Vathin Medical Instrument Co., Ltd.?
The most frequent FDA product codes under this applicant name are EOQ (Bronchoscope (Flexible Or Rigid), 6); FGB (Ureteroscope And Accessories, Flexible/Rigid, 5); EOB (Nasopharyngoscope (Flexible Or Rigid), 2).
Next steps
- See all 17 Hunan Vathin Medical Instrument Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EOQ, Hunan Vathin Medical Instrument 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.