Endobronchial Blocker Tube (12 models)— 510(k) K251950

Name: FDA 510(k) clearance K251950
Creator: U.S. Food and Drug Administration
Published: 2026-03-20

Substantially Equivalent

Hangzhou Tappa Medical Technology Co., Ltd.

FDA 510(k) clearance K251950 for Endobronchial Blocker Tube (12 models), Substantially Equivalent on 2026-03-20. Applicant: Hangzhou Tappa Medical Technology Co., Ltd.. Device class: 2.

Summary

Hangzhou Tappa Medical Technology's Endobronchial Blocker Tube comes in 12 listed models, EBT0109 through EBT0205S. They're filed under CBI, differential ventilation tracheal/bronchial tubes (with or without connector).

Class II, 21 CFR 868.5740. Anesthesiology is both the classification panel and the review panel. It was a Traditional 510(k).

Hangzhou Tappa Medical Technology filed from Hangzhou, China. The decision came 268 calendar days after receipt (June 25, 2025 to March 20, 2026).

Clearance details

Device name as filed: Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)
Applicant: Hangzhou Tappa Medical Technology Co., Ltd.
Product code: Product code CBI
Device class: Class 2
Regulation: 21 CFR 868.5740
Advisory panel: Anesthesiology
Date received: 2025-06-25
Decision date: 2026-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CBI

product code CBI

Death: 4
Malfunction: 594
Total: 598

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.