Cleared Traditional

HotDog Warming Mattress + Return Electrode (K230866) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230866 · Augustine Temperature Management, LLC · Cardiovascular device
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Jun 2023
Decision
92d
Days
Class 2
Risk

K230866 is an FDA 510(k) clearance for the HotDog Warming Mattress + Return Electrode. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Augustine Temperature Management, LLC (Minneapolis, US). The FDA issued a Cleared decision on June 29, 2023 after a review of 92 days - within the typical 510(k) review window.

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, LLC devices

Submission Details

510(k) Number K230866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2023
Decision Date June 29, 2023
Days to Decision 92 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
33d faster than avg
Panel avg: 125d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Augustine Temperature Management
Garrett Augustine

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DWJ System, Thermal Regulating

All 31
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K230866.
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HotDog Temperature Management System
K220941 · Augustine Temperature Management · Sep 2022
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K210605 · 3M Company · Apr 2021