Cleared Traditional

K141686 - EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY

K141686 is an FDA 510(k) clearance for EQUATOR CONVECTIVE WARMER, manufactured by Smith Medical Asd, Inc.. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K141686 · Smith Medical Asd, Inc. · Cardiovascular device
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Oct 2014
Decision
127d
Days
Class 2
Risk

K141686 is an FDA 510(k) clearance for the EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BL.... Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Smith Medical Asd, Inc. (St. Paul, US). The FDA issued a Cleared decision on October 28, 2014 after a review of 127 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 Smith Medical Asd, Inc. devices

FDA 510(k) Submission Details - K141686

510(k) Number K141686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2014
Decision Date October 28, 2014
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 130
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K141686.
Arctic Sun Temperature Management System
K161602 · Medivance, Inc. · Sep 2016
Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
K142702 · Medivance, Inc. · Dec 2014
TECOTHERM NEO (T NEO)
K140078 · Inspiration Healthcare, Ltd. · Nov 2014
COCOON CONVECTIVE WARMING SYSTEM
K140635 · Care Essentials Pty, Ltd. · Jul 2014
BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET
K132048 · Molnlycke Health Care Us, LLC · Nov 2013
VITAHEAT PATIENT WARMING SYSTEM
K132454 · Vitaheat Medical, LLC · Oct 2013