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FDA 510(k)

Warming System

K-Number: K252861 · 2026-04-07

ApplicantHangzhou Tappa Medical Technology Co., Ltd.
Decision Date2026-04-07
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Warming System is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Tappa Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-07 under 510(k) number K252861. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Warming System?

Warming System is a medical device that received FDA 510(k) clearance on 2026-04-07. The listed applicant is Hangzhou Tappa Medical Technology Co., Ltd.. The 510(k) number is K252861.

When did Warming System receive FDA 510(k) clearance?

Warming System received FDA 510(k) clearance on 2026-04-07, under 510(k) number K252861.

Who is the listed applicant for Warming System?

The FDA 510(k) record lists Hangzhou Tappa Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Warming System?

The FDA product code for Warming System is DWJ.

Other records listing Hangzhou Tappa Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251950Endobronchial 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)

Related Devices (Code: DWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbHK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.K242964Celsi WarmerHadleigh Health TechnologiesK243942Arctic Sun Stat Temperature Management SystemMedivance, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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