Cleared Traditional

K220941 - HotDog Temperature Management System

K220941 is an FDA 510(k) clearance for HotDog Temperature Management System, manufactured by Augustine Temperature Management. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K220941 · Augustine Temperature Management · Cardiovascular device
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Sep 2022
Decision
176d
Days
Class 2
Risk

K220941 is an FDA 510(k) clearance for the HotDog Temperature Management System. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Augustine Temperature Management (Minneapolis, US). The FDA issued a Cleared decision on September 23, 2022 after a review of 176 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5900 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Augustine Temperature Management devices

FDA 510(k) Submission Details - K220941

510(k) Number K220941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2022
Decision Date September 23, 2022
Days to Decision 176 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 125d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWJ Device Classification - Class 2, Special Controls

Product Code DWJ System, Thermal Regulating
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWJ System, Thermal Regulating

All 63
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K220941.
IOB Temperature Management System
K231596 · Iob Medical, Inc. · Jun 2023
HotDog Warming Mattress + Return Electrode
K230866 · Augustine Temperature Management, LLC · Jun 2023
IOB Warming Blankets
K221669 · Iob Medical, Inc. · Dec 2022
3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation
K210605 · 3M Company · Apr 2021
3M Bair Hugger Temperature Management System (Model 675)
K210603 · 3M Company · Mar 2021
NOVA Patient Warming System
K203085 · Encompass Group, LLC · Nov 2020