Cleared Special

K040632 - SNUGGLE WARM 4000 CONVECTIVE WARMING SY...

K040632 is the FDA 510(k) clearance for SNUGGLE WARM 4000 CONVECTIVE WARMING SY... by Smiths Medical Asd, Inc.. It is a Class 2 Cardiovascular device (product code DWJ) cleared through the Special 510(k) pathway after a 48-day FDA review.

K040632 · Smiths Medical Asd, Inc. · Cardiovascular device
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Apr 2004
Decision
48d
Days
Class 2
Risk

K040632 is an FDA 510(k) clearance for the SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (Rockland, US). The FDA issued a Cleared decision on April 27, 2004 after a review of 48 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 Smiths Medical Asd, Inc. devices

Submission Details

510(k) Number K040632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2004
Decision Date April 27, 2004
Days to Decision 48 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
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Modification to existing cleared device.

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 Peers - DWJ System, Thermal Regulating

All 41
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K040632.
COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT
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LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL
K083336 · Smiths Medical Asd, Inc. · Jun 2009
LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET
K061513 · Smiths Medical Asd, Inc. · Aug 2006
KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS
K033021 · Kimberly-Clark Corp. · Nov 2003
WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300
K020604 · Nellcor Puritan Bennett, Inc. · Apr 2002
WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860
K014121 · Nellcor Puritan Bennett, Inc. · Jan 2002