Cleared Special

K053645 - MODIFICATION TO:BAIR HUGGER TEMPERATURE...

K053645 is an FDA 510(k) clearance for MODIFICATION TO:BAIR HUGGER TEMPERATURE..., manufactured by Arizant Healthcare, Inc.. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Special 510(k) pathway after a 69-day FDA review.

K053645 · Arizant Healthcare, Inc. · Cardiovascular device
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Mar 2006
Decision
69d
Days
Class 2
Risk

K053645 is an FDA 510(k) clearance for the MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Arizant Healthcare, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on March 9, 2006 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5900 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Arizant Healthcare, Inc. devices

FDA 510(k) Submission Details - K053645

510(k) Number K053645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2005
Decision Date March 09, 2006
Days to Decision 69 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 125d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

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 64
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K053645.
MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
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