FDA cleared the Warming System from Hangzhou Tappa Medical Technology Co., Ltd. on Apr 7, 2026 under K252861, a traditional 510(k). The device falls under product code DWJ, System, Thermal Regulating, regulated at 21 CFR 870.5900 as a Class 2 device. The review panel was Cardiovascular.
FDA logged the submission as received on Sep 9, 2025. The decision came 210 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: K251950 (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)).