510(k) Report

510(k) · Cleared

Cleared

Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg Warmer Thermal Blanket

K031728510(k) TraditionalCleared Oct 12, 2004496-day reviewClass II21 CFR 870.5900

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

Klimamed Technologie Medizingerate GmbH · DWJ System, Thermal Regulating

Cleared on Oct 12, 2004 as substantially equivalent to K011859 (Klimamed Technologie Medizingerate GmbH, 2002) after a 496-day review. Its family tree reaches back 1 generation to 2002. 10 later devices descend from it.

Decided
Oct 12, 2004
Review
496 days
Class
Class II
Product code
DWJ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K011859 (2002). 10 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared2020: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant clearedK011859 · Klimamed Thermal Mat & Controller 95 and 55 Watts · Klimamed Technologie Medizingerate GmbH · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 1 descendant K011859 · Klimamed Thermal Mat & Controller 95 and 55 Watts · Klimamed Technologie Medizingerate GmbH · 20020+5
  1. Root · 1 generation backK011859 Klimamed Thermal Mat & Controller 95 and 55 WattsKlimamed Technologie Medizingerate GmbH · 2002
  2. This deviceK031728 Klimamed Thermal Blankets, Including Arm Shoulder West Thermal…Klimamed Technologie Medizingerate GmbH · 2004
  3. Descendant · cites it directly · 9 of its ownK051419 Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1…Inditherm Medical · 2006
  4. Descendant · 2 generations on · 6 of its ownK092807 Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and…Augustine Biomedical & Design, LLC · 2009
  5. Descendant · 3 generations on · 4 of its ownK094056 Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC · 2010
  6. Descendant · 4 generations on · 3 of its ownK201779 HotDog Temperature Management ControllerAugustine Temperature Management · 2020 · Recalled
  7. Descendant · 5 generations on · 2 of its ownK220941 HotDog Temperature Management SystemAugustine Temperature Management · 2022 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006: 22008: 12009: 12010: 12013: 12020: 12022: 12023: 12024: 1
2006high 2 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 10 · See all
  • K051419Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1Inditherm Medical · 2006 · cites it directly9descendants
  • K092807Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103Augustine Biomedical & Design, LLC · 2009 · 2 generations on6descendants
  • K094056Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC · 2010 · 3 generations on4descendants
  • K201779HotDog Temperature Management ControllerAugustine Temperature Management · 2020 · 4 generations on3descendants
  • K220941HotDog Temperature Management SystemAugustine Temperature Management · 2022 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011859Klimamed Thermal Mat & Controller 95 and 55 WattsKlimamed Technologie Medizingerate GmbH2002—
0 (this device)K031728Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg…Klimamed Technologie Medizingerate GmbH2004—
+1K051419Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1Inditherm Medical2006—
+2K092807Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103Augustine Biomedical & Design, LLC2009—
+3K094056Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC2010—
+4K201779HotDog Temperature Management ControllerAugustine Temperature Management20204
+5K220941HotDog Temperature Management SystemAugustine Temperature Management20224

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200810
200910
201010
201310
202010
202210
202310
202410
FIG. 1 — Lineage of K031728, 2002–2024Source: 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
*K011859Klimamed Thermal Mat & Controller 95 and 55 WattsKlimamed Technologie Medizingerate GmbH2002—

Also cleared against K011859: 3 other devices →

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051419Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1Inditherm Medical20069

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K051419 (Inditherm Medical, 2006) has gone furthest, with 9 descendants of its own.
  • 3 other devices also cite its predicate K011859.

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 device is intended to warming pre-set body temperature as determined by the physician. It can also be utilized to warming normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors. The device has heating capability, not cooling.

Indications for use as stated in the FDA summary.

Also cleared against K011859

3 other devices cite the same predicate.

  • K080763Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700 HTTalley Medical · 2008
  • K062794PRN Thermalcare, Model 3000American Healthcare Products, Inc. · 2006
  • K051419Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1Inditherm Medical · 2006

More from Klimamed Technologie Medizingerate GmbH

2 FDA decisions under this applicant name. See the company

  • K011859Klimamed Thermal Mat & Controller 95 and 55 WattsKlimamed Technologie Medizingerate GmbH · 2002

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/K031728 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031728: Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg Warmer Thermal Blanket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031728

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026