Disposable Warming Blanket

Q: What is the product code of K262089?

The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.

FDA 510(k) K262089 · Hangzhou Tappa Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK262089

Submission

Device name: Disposable Warming Blanket
Applicant: Hangzhou Tappa Medical Technology Co., Ltd.
Hangzhou, CN
Received: June 22, 2026
Decision date: August 21, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DWJ – System, Thermal Regulating
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.5900
Specialty: Cardiovascular

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other 510(k)s with product code DWJ

510(k)	Device	Applicant	Decision
K261437	Mistral-Air® Warming SystemDWJ · Special	The Surgical Company International B.V., doing…	08/07/2026SE
K260278	ThermAffyx(TM) Patient Safety SystemDWJ · Traditional	Stihler Electronic GmbH	07/08/2026SE
K260903	Hot Pink Pad Warming SystemDWJ · Traditional	Xodus Medical, Inc.	04/16/2026SE
K252861	Warming SystemDWJ · Traditional	Hangzhou Tappa Medical Technology Co., Ltd.	04/07/2026SE
K251974	Arctic Sun Temperature Management System (Model 5000)DWJ · Traditional	Medivance, Inc.	10/24/2025SE
K242964	Celsi WarmerDWJ · Traditional	Hadleigh Health Technologies	06/20/2025SE
K243942	Arctic Sun Stat Temperature Management SystemDWJ · Traditional	Medivance, Inc.	04/30/2025SE
K232627	HotDog Warming Mattress + Return ElectrodeDWJ · Special	Augustine Temperature Management, LLC	04/18/2024SE
K232502	Cocoon Convective Warming System, Model CWS7000DWJ · Traditional	Care Essentials Pty, Ltd.	02/21/2024SE
K231211	Medline ComfortTemp Patient Warming SystemDWJ · Traditional	Medline Industries, LP	12/01/2023SE

More from Medline Industries, LP

510(k)	Device	Decision
K252861	Warming SystemDWJ · Traditional	04/07/2026SE
K251950	Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107)…CBI · Traditional	03/20/2026SE

Questions and answers

When was Disposable Warming Blanket cleared by the FDA?

Disposable Warming Blanket (K262089) received a 510(k) decision of Substantially Equivalent on August 21, 2026, 60 days after the submission was received.

What is the product code of K262089?

The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.