Cleared Special

HotDog Warming Mattress + Return Electrode

K232627 · Augustine Temperature Management, LLC · Cardiovascular

Apr 2024

Decision

233d

Days

Class 2

Risk

About This 510(k) Submission

K232627 is an FDA 510(k) clearance for the HotDog Warming Mattress + Return Electrode, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Augustine Temperature Management, LLC (Minneapolis, US). The FDA issued a Cleared decision on April 18, 2024, 233 days after receiving the submission on August 29, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K232627 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 2023
Decision Date	April 18, 2024
Days to Decision	233 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DWJ — System, Thermal Regulating
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5900
Definition	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).