Hotdog Patient Warming System

Q: What is the product code of K112488?

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

FDA 510(k) K112488 · Augustine Biomedical & Design, LLC

Substantially Equivalent

510(k) numberK112488

Submission

Device name: Hotdog Patient Warming System
Applicant: Augustine Biomedical & Design, LLC
Eden Prairie, MN, US
Received: August 29, 2011
Decision date: November 23, 2011
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
K262089	Disposable Warming BlanketDWJ · Traditional	Hangzhou Tappa Medical Technology Co., Ltd.	08/21/2026SE
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

More from Care Essentials Pty, Ltd.

510(k)	Device	Decision
K094056	Hotdog Multi Function ControllerDWJ · Traditional	06/03/2010SE
K092807	Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103DWJ · Traditional	12/10/2009SE
K052392	Hot Dog Patient Warming SystemDWJ · Traditional	05/04/2006SE

Questions and answers

When was Hotdog Patient Warming System cleared by the FDA?

Hotdog Patient Warming System (K112488) received a 510(k) decision of Substantially Equivalent on November 23, 2011, 86 days after the submission was received.

What is the product code of K112488?

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