FDA cleared the Disposable Warming Blanket from Hangzhou Tappa Medical Technology Co., Ltd. on Aug 21, 2026 under K262089, 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 Jun 22, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).
Hangzhou Tappa Medical Technology Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K252861 (Warming System), 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)).