Single-Use flexible Video Bronchoscope
Model BCV1-02 · Hunan Vathin Medical Instrument Co., Ltd · DI 06972197480016
EOQ — Bronchoscope (Flexible Or Rigid) · Class II · 21 CFR 874.4680
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.2 |
| 2019-02 | 0 | 1.5 |
| 2019-03 | 0 | 6.89 |
| 2019-04 | 0 | 44.75 |
| 2019-05 | 0 | 4 |
| 2019-06 | 0 | 3 |
| 2019-07 | 0 | 2.54 |
| 2019-08 | 0 | 4.78 |
| 2019-09 | 0 | 2.78 |
| 2019-10 | 0 | 2.57 |
| 2019-11 | 0 | 2.4 |
| 2019-12 | 0 | 4.25 |
| 2020-01 | 0 | 2.92 |
| 2020-02 | 0 | 6.2 |
| 2020-03 | 0 | 2.33 |
| 2020-04 | 0 | 4.31 |
| 2020-05 | 0 | 2.93 |
| 2020-06 | 0 | 4.24 |
| 2020-07 | 0 | 4.65 |
| 2020-08 | 0 | 4.5 |
| 2020-09 | 0 | 3.76 |
| 2020-10 | 0 | 3.91 |
| 2020-11 | 0 | 4.52 |
| 2020-12 | 0 | 6.57 |
| 2021-01 | 0 | 4.39 |
| 2021-02 | 0 | 4.04 |
| 2021-03 | 0 | 5.57 |
| 2021-04 | 0 | 4.75 |
| 2021-05 | 0 | 5.1 |
| 2021-06 | 0 | 4.02 |
| 2021-07 | 0 | 3.22 |
| 2021-08 | 0 | 4.9 |
| 2021-09 | 0 | 4.18 |
| 2021-10 | 0 | 4.75 |
| 2021-11 | 0 | 3.93 |
| 2021-12 | 0 | 4.87 |
| 2022-01 | 0 | 4.98 |
| 2022-02 | 0 | 4.54 |
| 2022-03 | 0 | 6.65 |
| 2022-04 | 0 | 6.56 |
| 2022-05 | 0 | 5.72 |
| 2022-06 | 0 | 6.05 |
| 2022-07 | 0 | 6.22 |
| 2022-08 | 0 | 5.78 |
| 2022-09 | 0 | 5.19 |
| 2022-10 | 0 | 5.56 |
| 2022-11 | 0 | 5.65 |
| 2022-12 | 0 | 5.77 |
| 2023-01 | 0 | 8 |
| 2023-02 | 0 | 5.67 |
| 2023-03 | 0 | 7.22 |
| 2023-04 | 0 | 5.99 |
| 2023-05 | 0 | 6.6 |
| 2023-06 | 0 | 6.31 |
| 2023-07 | 0 | 6.17 |
| 2023-08 | 0 | 7.54 |
| 2023-09 | 0 | 6.8 |
| 2023-10 | 0 | 6.71 |
| 2023-11 | 0 | 7.17 |
| 2023-12 | 0 | 7.04 |
| 2024-01 | 0 | 6.36 |
| 2024-02 | 0 | 6.05 |
| 2024-03 | 0 | 7.21 |
| 2024-04 | 0 | 6.19 |
| 2024-05 | 0 | 6.2 |
| 2024-06 | 0 | 7.13 |
| 2024-07 | 0 | 6.06 |
| 2024-08 | 0 | 7.7 |
| 2024-09 | 0 | 6.97 |
| 2024-10 | 0 | 8.15 |
| 2024-11 | 0 | 10.86 |
| 2024-12 | 0 | 4.17 |
| 2025-01 | 0 | 4.16 |
| 2025-02 | 0 | 3.73 |
| 2025-03 | 0 | 4.21 |
| 2025-04 | 0 | 4.31 |
| 2025-05 | 0 | 4.93 |
| 2025-06 | 0 | 4.86 |
| 2025-07 | 0 | 5.79 |
| 2025-08 | 0 | 5.13 |
| 2025-09 | 0 | 4.38 |
| 2025-10 | 0 | 5.19 |
| 2025-11 | 0 | 6.62 |
| 2025-12 | 0 | 10.31 |
| 2026-01 | 0 | 8.47 |
| 2026-02 | 0 | 6.48 |
| 2026-03 | 0 | 6.61 |
| 2026-04 | 0 | 8.85 |
| 2026-05 | 0 | 9.34 |
| 2026-06 | 0 | 8.3 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K191828 — cites (transitively): K173727 (d1), K091768 (d2), K161656 (d2), K121959 (d3), K130485 (d3), K130845 (d3), K051645 (d4), K061313 (d4), K062049 (d4), K100584 (d4), K023984 (d4), K110962 (d4), K981543 (d4) — cited as predicate by K202346, K210379, K221581, K231107, K242010, K243541
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Hunan Vathin Medical Instrument Co., Ltd
Nothing in the loaded window.