Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hunan Vathin Medical Instrument Co., Ltd. · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
144 daysmedian FDA review time
260 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250232 | Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2025-07-25 | 179 | 0 |
| K251599 | Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. | 2025-07-03 | 37 | 0 |
| K250785 | Single-use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | 2025-05-06 | 53 | 0 |
| K243117 | Digital Video Processor | Hunan Vathin Medical Instrument Co., Ltd. | 2025-01-29 | 121 | 0 |
| K242416 | Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C | Hunan Vathin Medical Instrument Co., Ltd. | 2025-01-16 | 154 | 0 |
| K242535 | Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F0 | Hunan Vathin Medical Instrument Co., Ltd. | 2024-12-18 | 114 | 0 |
| K241612 | Video Bronchoscope System; Single-use Flexible Bronchoscope | Hunan Vathin Medical Instrument Co., Ltd. | 2024-10-29 | 146 | 0 |
| K240167 | Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. | 2024-10-08 | 260 | 0 |
| K241434 | Video Ureteroscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2024-10-04 | 136 | 0 |
| K231135 | Video Ureteroscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2024-01-17 | 271 | 0 |
| K230536 | Single-use Flexible Rhinolaryngoscope; Digital Video Monitor | Hunan Vathin Medical Instrument Co., Ltd. | 2023-06-14 | 107 | 0 |
| K230200 | Single-Use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | 2023-05-18 | 113 | 0 |
| K223836 | Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2023-05-15 | 144 | 0 |
| K221580 | Single-Use Flexible Cystoscope | Hunan Vathin Medical Instrument Co., Ltd. | 2022-11-18 | 170 | 0 |
| K221581 | Single-Use Flexible Rhinolaryngoscope | Hunan Vathin Medical Instrument Co., Ltd. | 2022-11-18 | 170 | 0 |
| K213635 | Vathin Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2022-02-28 | 103 | 0 |
| K191828 | Vathin Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2020-02-13 | 220 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda