510(k) Report

510(k) · Cleared

Recalled · 2004

Snuggle Warm 4000 Convective Warming System

K011907510(k) TraditionalCleared Dec 18, 2001183-day reviewClass II21 CFR 870.5900Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sims Level 1, Inc. · DWJ System, Thermal Regulating

Cleared on Dec 18, 2001 as substantially equivalent to K904690 (Marquest Medical Products, Inc., 1991) after a 183-day review. Its family tree reaches back 1 generation to 1991. 8 later devices descend from it. It has been recalled once.

Decided
Dec 18, 2001
Review
183 days
Class
Class II
Product code
DWJ
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K904690 (1991). 8 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2014: 1 descendant cleared2006: 1 descendant cleared2012: 2 descendants cleared2010: 1 descendant cleared2013: 1 descendant cleared2018: 1 descendant clearedK904690 · Temp Marq (TM) Convective Warming System · Marquest Medical Products, Inc. · 19911990200020102020
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 3 descendants K904690 · Temp Marq (TM) Convective Warming System · Marquest Medical Products, Inc. · 19910
  1. Root · 1 generation backK904690 Temp Marq (TM) Convective Warming SystemMarquest Medical Products, Inc. · 1991
  2. This deviceK011907 Snuggle Warm 4000 Convective Warming SystemSims Level 1, Inc. · 2001
  3. Descendant · cites it directly · 3 of its ownK061513 Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody BlanketSmiths Medical Asd, Inc. · 2006
  4. Descendant · cites it directly · 2 of its ownK101148 Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc. · 2010 · Recalled
  5. Descendant · cites it directly · 2 of its ownK083336 Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket…Smiths Medical Asd, Inc. · 2009
  6. Descendant · cites it directly · 1 of its ownK141686 Equator Convective Warmer, Snuggle Warm Adult Full Body Convective…Smith Medical Asd, Inc. · 2014
  7. Descendant · 2 generations on · 1 of its ownK121669 Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc. · 2012

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2006: 12009: 12010: 12012: 22013: 12014: 12018: 1
2006high 2 (2012) · low 0 (2007)2026

Most influential descendants

Showing 5 of 8 · See all
  • K061513Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody BlanketSmiths Medical Asd, Inc. · 2006 · cites it directly3descendants
  • K101148Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc. · 2010 · cites it directly2descendants
  • K083336Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model SW-2013, Level 1…Smiths Medical Asd, Inc. · 2009 · cites it directly2descendants
  • K141686Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket…Smith Medical Asd, Inc. · 2014 · cites it directly1descendant
  • K121669Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc. · 2012 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K904690Temp Marq (TM) Convective Warming SystemMarquest Medical Products, Inc.1991—
0 (this device)K011907Snuggle Warm 4000 Convective Warming SystemSims Level 1, Inc.2001—
+1K061513Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody BlanketSmiths Medical Asd, Inc.2006—
+1K101148Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc.20102
+1K083336Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model…Smiths Medical Asd, Inc.2009—
+1K141686Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming…Smith Medical Asd, Inc.2014—
+2K121669Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
201010
201220
201310
201410
201810
FIG. 1 — Lineage of K011907, 1991–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DWJ device

  1. #1 K260278 ThermAffyx (TM) Patient Safety Systemscore 12.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K904690Temp Marq (TM) Convective Warming System
Summary page 1
…he legally marketed predicate device currently in commercial distribution is the Temp Marq™/ Snuggle Warm Convective Warming System. described in premarket notification K904690 and cleared for market on February 1. 1991, 8. Description of device: The Snuggle Warm consists of a disposable…
Marquest Medical Products, Inc.1991—

Also cleared against K904690: 1 other device →

What descends from it? (8)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061513Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody BlanketSmiths Medical Asd, Inc.20063
K101148Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc.20102
K083336Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model SW-2013, Level 1…Smiths Medical Asd, Inc.20092
K141686Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket…Smith Medical Asd, Inc.20141
K120081Norm-O-Temp Hyperthermia System Incliding Blankets/PadsCincinnati Sub-Zero Products, Inc.20120

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 15, 2004Not classifiedZ-0497-05OtherWarmer heater coil may come in contact with the filter housing, causing a small area of the plastic housing to melt

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K061513 (Smiths Medical Asd, Inc., 2006) has gone furthest, with 3 descendants of its own.
  • 1 other device also cites its predicate K904690.

How does its category compare?

All DWJ devices

DWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWJ

3in 2025

2007: 42008: 32009: 32010: 82011: 42012: 52013: 52014: 42016: 22017: 52018: 32019: 22020: 52021: 22022: 22023: 62024: 22025: 32026 (partial year): 5
2007high 8 (2010) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWJ

131in 2025

2007: 106 days median2008: 73 days median2009: 106 days median2010: 134 days median2011: 180 days median2012: 69 days median2013: 77 days median2014: 131 days median2017: 153 days median2018: 95 days median2020: 30 days median2023: 42 days median2025: 131 days median2026 (partial year): 99 days median
2007high 180 (2011) · low 30 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DWJ

3in 2024

2009: 62010: 22011: 72012: 12013: 22015: 12017: 32018: 52019: 32020: 22021: 12022: 52024: 32026 (partial year): 3
2007high 7 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DWJ

2,384in 2025

2007: 522008: 402009: 712010: 1042011: 1362012: 1062013: 732014: 1162015: 2452016: 1,4002017: 1,4732018: 1,5172019: 2,2942020: 2,5462021: 2,6892022: 3,2262023: 3,4552024: 3,3292025: 2,384
2007high 3,455 (2023) · low 40 (2008)2025

MAUDE reports naming product code DWJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074106052
2008373040
20093106671
201081342104
201141807136
20125691106
2013577273
201441310116
20150—1245
20162—01,400
2017515331,473
201839551,517
20192—32,294
202053022,546
20212—12,689
20222—53,226
202364203,455
20242—33,329
2025313102,384
20265993—

What is it indicated for?

The Snuggle Warm 4000 Convective Warming System is intended for thermal regulating a patient’s temperature to prevent hypothermia by a warm air heated blanket system (o reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K904690

1 other device cites the same predicate.

  • K963731Tru-5000 Thermal Recovery Radiant Heating UnitEnthermics Medical Systems, Inc. · 1997

More from Sims Level 1, Inc.

2 FDA decisions under this applicant name. See the company

  • K001764Hotline 2 Fluid WarmerSims Level 1, Inc. · 2000

Recent decisions in DWJ

The DWJ category page

  • K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd. · 2026
  • K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life · 2026
  • K260278ThermAffyx (TM) Patient Safety SystemStihler Electronic GmbH · 2026
  • K260903Hot Pink Pad Warming SystemXodus Medical, Inc. · 2026
  • K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd. · 2026

https://510kreport.com/device/K011907 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011907: Snuggle Warm 4000 Convective Warming System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011907

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026