Warming System— 510(k) K252861

Name: FDA 510(k) clearance K252861
Creator: U.S. Food and Drug Administration
Published: 2026-04-07

Substantially Equivalent

Hangzhou Tappa Medical Technology Co., Ltd.

FDA 510(k) clearance K252861 for Warming System, Substantially Equivalent on 2026-04-07. Applicant: Hangzhou Tappa Medical Technology Co., Ltd.. Device class: 2.

Summary

Hangzhou Tappa Medical Technology's Warming System is filed under product code DWJ (System, Thermal Regulating). The name is generic.

Class II, 21 CFR 870.5900. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Hangzhou Tappa Medical Technology filed from Hangzhou, China. The decision came 210 calendar days after FDA received it (September 9, 2025 to April 7, 2026).

Clearance details

Applicant: Hangzhou Tappa Medical Technology Co., Ltd.
Product code: Product code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2025-09-09
Decision date: 2026-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWJ

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K263587 — Arctic Sun Neonatal ArcticGel Pad2026-10-30
K262089 — Disposable Warming Blanket2026-08-21
K261437 — Mistral-Air® Warming System2026-08-07
K260278 — ThermAffyx(TM) Patient Safety System2026-07-08
K260903 — Hot Pink Pad Warming System2026-04-16

More clearances from Hangzhou Tappa Medical Technology Co., Ltd.

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K251950 — Endobronchial Blocker Tube (12 models)2026-03-20

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.