Cleared Traditional

K011907 - SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM

K011907 is an FDA 510(k) clearance for SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, manufactured by Sims Level 1, Inc.. The device is a Class 2 Cardiovascular device with product code DWJ cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K011907 · Sims Level 1, Inc. · Cardiovascular device
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Dec 2001
Decision
183d
Days
Class 2
Risk

K011907 is an FDA 510(k) clearance for the SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Sims Level 1, Inc. (Rockland, US). The FDA issued a Cleared decision on December 18, 2001 after a review of 183 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.

View all Sims Level 1, Inc. devices

FDA 510(k) Submission Details - K011907

510(k) Number K011907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2001
Decision Date December 18, 2001
Days to Decision 183 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 125d · This submission: 183d
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 92
Devices cleared under the same product code (DWJ) and FDA review panel - the closest regulatory comparables to K011907.
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
K021473 · Augustine Medical, Inc. · Jul 2002
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
AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
K001149 · Augustine Medical, Inc. · Sep 2000
WESCO BLANKET
K981093 · Wesco, Inc. · Mar 2000
ALLON 2000
K992386 · Mtre Advanced Technology , Ltd. · Mar 2000