Cleared Traditional

K094056 - HOTDOG MULTI FUNCTION CONTROLLER

K094056 is an FDA 510(k) clearance for HOTDOG MULTI FUNCTION CONTROLLER, manufactured by Augustine Biomedical & Design, LLC. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K094056 · Augustine Biomedical & Design, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
154d
Days
Class 2
Risk

K094056 is an FDA 510(k) clearance for the HOTDOG MULTI FUNCTION CONTROLLER. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Augustine Biomedical & Design, LLC (Eden Prairie, US). The FDA issued a Cleared decision on June 3, 2010 after a review of 154 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.

FDA 510(k) Submission Details - K094056

510(k) Number K094056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2009
Decision Date June 03, 2010
Days to Decision 154 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 147
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K094056.
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CRITICOOL
K083662 · Mtre Advanced Technology , Ltd. · Mar 2009
K094056 · HOTDOG MULTI FUNCTION CONTROLLER
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