Cleared Traditional

K251950 - Endobronchial Blocker Tube (EBT0109) (FDA 510(k) Clearance)

Also includes:
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)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251950 · Hangzhou Tappa Medical Technology Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
268d
Days
Class 2
Risk

K251950 is an FDA 510(k) clearance for the Endobronchial Blocker Tube (EBT0109). Classified as Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (product code CBI), Class II - Special Controls.

Submitted by Hangzhou Tappa Medical Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 20, 2026 after a review of 268 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5740 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hangzhou Tappa Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K251950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2025
Decision Date March 20, 2026
Days to Decision 268 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 139d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBI Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.