Cleared Special

K060865 - BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850

K060865 is an FDA 510(k) clearance for BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM..., 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 25-day FDA review.

K060865 · Arizant Healthcare, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
25d
Days
Class 2
Risk

K060865 is an FDA 510(k) clearance for the BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850. 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 April 24, 2006 after a review of 25 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 - K060865

510(k) Number K060865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2006
Decision Date April 24, 2006
Days to Decision 25 days
Submission Type Special
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
100d faster than avg
Panel avg: 125d · This submission: 25d
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 132
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K060865.
GERATHERM SOS-RESCUE BAG
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K051419 · Inditherm Medical · Apr 2006
MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
K053645 · Arizant Healthcare, Inc. · Mar 2006
GERATHERM SOS-RESCUE BLANKET
K051097 · Rg Ent., Inc. · Feb 2006
KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET
K031728 · Klimamed Technologie Medizingerate GmbH · Oct 2004