FDA cleared the 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) from Hangzhou Tappa Medical Technology Co., Ltd. on Mar 20, 2026 under K251950, a traditional 510(k). The device falls under product code CBI, Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector), regulated at 21 CFR 868.5740 as a Class 2 device. The review panel was Anesthesiology.
FDA logged the submission as received on Jun 25, 2025. The decision came 268 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Hangzhou Tappa Medical Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K252861 (Warming System).
Questions & Answers
What did FDA clear under K251950?
K251950 is the FDA 510(k) for 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), submitted by Hangzhou Tappa Medical Technology Co., Ltd.. FDA's decision date was Mar 20, 2026, under product code CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)).
Who makes the 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)?
Hangzhou Tappa Medical Technology Co., Ltd., based in Hangzhou, is the applicant of record for K251950.
How long did the K251950 review take?
FDA received the submission on Jun 25, 2025 and issued its decision on Mar 20, 2026, 268 days later.