Atlas FDA

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-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250232Vathin® Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd.2025-07-251790
K251599Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd.2025-07-03370
K250785Single-use Flexible UreteroscopeHunan Vathin Medical Instrument Co., Ltd.2025-05-06530
K243117Digital Video ProcessorHunan Vathin Medical Instrument Co., Ltd.2025-01-291210
K242416Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1CHunan Vathin Medical Instrument Co., Ltd.2025-01-161540
K242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F0Hunan Vathin Medical Instrument Co., Ltd.2024-12-181140
K241612Video Bronchoscope System; Single-use Flexible Bronchoscope Hunan Vathin Medical Instrument Co., Ltd.2024-10-291460
K240167Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd.2024-10-082600
K241434Video Ureteroscope SystemHunan Vathin Medical Instrument Co., Ltd.2024-10-041360
K231135Video Ureteroscope SystemHunan Vathin Medical Instrument Co., Ltd.2024-01-172710
K230536Single-use Flexible Rhinolaryngoscope; Digital Video MonitorHunan Vathin Medical Instrument Co., Ltd.2023-06-141070
K230200Single-Use Flexible UreteroscopeHunan Vathin Medical Instrument Co., Ltd.2023-05-181130
K223836Vathin® Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd.2023-05-151440
K221580Single-Use Flexible CystoscopeHunan Vathin Medical Instrument Co., Ltd.2022-11-181700
K221581Single-Use Flexible RhinolaryngoscopeHunan Vathin Medical Instrument Co., Ltd.2022-11-181700
K213635Vathin Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd.2022-02-281030
K191828Vathin Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd.2020-02-132200

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