# Hunan Vathin Medical Instrument Co., Ltd.

- Location (FDA's records): Xiangtan, CN
- FDA decisions: 18 (2020–2026): 18 510(k) clearances
- Product codes: EOQ (7), FGB (5), FAJ (2), EOB (2), FED (2)
- 510(k) review time since 2016: median 140 days, against 141 for FDA's reviews in the same codes and years (10 of 18 faster)
- Predicates its devices cite: 20 (3 its own); citations of its devices by later devices: 10 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ambu A/S: 9 (https://510kreport.com/company/ambu-a-s)
- Verathon Medical (Canada) Ulc: 3 (https://510kreport.com/company/verathon-medical-canada-ulc)
- Zhuhai Pusen Medical Technology Co., Ltd.: 3 (https://510kreport.com/company/zhuhai-pusen-medical-technology)
- Suzhou Beyo Medical Technology Co., Ltd.: 2 (https://510kreport.com/company/suzhou-beyo-medical-technology)

## Firms that cite its devices most
- Hunan Endoso Life Technology Co., Ltd.: 2 (https://510kreport.com/company/hunan-endoso-life-technology)
- Shenzhen Sanping Image Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-sanping-image-technology)
- Contra Healthcare Solutions, LLC: 1 (https://510kreport.com/company/contra-healthcare-solutions)
- Dongguan Zsr Biomedical Technology Company Limited: 1 (https://510kreport.com/company/dongguan-zsr-biomedical-technology)
- Veran Medical Technologies, Inc.: 1 (https://510kreport.com/company/veran-medical-technologies)
- Scivita Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/scivita-medical-technology)

## Its most-cited devices
- K191828: Vathin Video Bronchoscope System (2020), cited by 5
- K230200: Single-Use Flexible Ureteroscope (2023), cited by 2
- K240167: Single-use Ureteral Access Sheath (2024), cited by 1
- K231135: Video Ureteroscope System (2024), cited by 1
- K223836: Vathin® Video Bronchoscope System (2023), cited by 1

## Recent decisions
- K261637: Single-use Flexible Bronchoscope (Sep 23, 2026)
- K250232: Vathin® Video Bronchoscope System (Jul 25, 2025)
- K251599: Single-use Ureteral Access Sheath (Jul 3, 2025)
- K250785: Single-use Flexible Ureteroscope (May 6, 2025)
- K243117: Digital Video Processor (Jan 29, 2025)
- 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 (Jan 16, 2025)
- 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) (Dec 18, 2024)
- 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) (Oct 29, 2024)

Source page: https://510kreport.com/company/hunan-vathin-medical-instrument