510(k) Report

510(k) · Cleared

Cleared

Hotdog Patient Warming System

K112488510(k) TraditionalCleared Nov 23, 201186-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

Augustine Biomedical & Design, LLC · DWJ System, Thermal Regulating

Cleared on Nov 23, 2011 as substantially equivalent to K052392 (Augustine Biomedical & Design, LLC, 2006) after an 86-day review. Its family tree reaches back 3 generations to 2000. 6 later devices descend from it.

Decided
Nov 23, 2011
Review
86 days
Class
Class II
Product code
DWJ
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K991684 (2000). 4 ancestors in all. 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2020: 2 descendants cleared2013: 1 descendant cleared2023: 1 descendant cleared2026: 2 descendants clearedK991684 · Chillbuster Portable Electric Blanket System, Model 8001 · Thermogear, Inc. · 2000K022903 · Chillbuster · Microtek Medical, Inc. · 2002K052392 · Hot Dog Patient Warming System · Augustine Biomedical & Design, LLC · 2006200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 3 descendants K052392 · Hot Dog Patient Warming System · Augustine Biomedical & Design, LLC · 2006K022903 · Chillbuster · Microtek Medical, Inc. · 2002K991684 · Chillbuster Portable Electric Blanket System, Model 8001 · Thermogear, Inc. · 20000
  1. Root · 3 generations backK991684 Chillbuster Portable Electric Blanket System, Model 8001Thermogear, Inc. · 2000
  2. 2 generations backK022903 ChillbusterMicrotek Medical, Inc. · 2002
  3. 1 generation backK052392 Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC · 2006
  4. This deviceK112488 Hotdog Patient Warming SystemAugustine Biomedical & Design, LLC · 2011
  5. Descendant · cites it directly · 2 of its ownK202197 Astopad Patient Warming SystemStihler Electronic GmbH · 2020
  6. Descendant · cites it directly · 1 of its ownK132048 Barrier Easywarm Active Self-Warming BlanketMolnlycke Health Care Us, LLC · 2013
  7. Descendant · 2 generations on · 0 of its ownK260278 ThermAffyx (TM) Patient Safety SystemStihler Electronic GmbH · 2026
  8. Descendant · 2 generations on · 0 of its ownK260903 Hot Pink Pad Warming SystemXodus Medical, Inc. · 2026
  9. Descendant · 2 generations on · 0 of its ownK232508 Barrier EasyWarm Active Self-Warming BlanketMolnlycke Health Care Us, LLC · 2023

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2013: 12020: 22023: 12026: 2
2013high 2 (2020) · low 0 (2014)2026

Most influential descendants

Showing 5 of 6 · See all
  • K202197Astopad Patient Warming SystemStihler Electronic GmbH · 2020 · cites it directly2descendants
  • K132048Barrier Easywarm Active Self-Warming BlanketMolnlycke Health Care Us, LLC · 2013 · cites it directly1descendant
  • K260278ThermAffyx (TM) Patient Safety SystemStihler Electronic GmbH · 2026 · 2 generations on0descendants
  • K260903Hot Pink Pad Warming SystemXodus Medical, Inc. · 2026 · 2 generations on0descendants
  • K232508Barrier EasyWarm Active Self-Warming BlanketMolnlycke Health Care Us, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K991684Chillbuster Portable Electric Blanket System, Model 8001Thermogear, Inc.2000—
−2K022903ChillbusterMicrotek Medical, Inc.2002—
−1K052392Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC2006—
0 (this device)K112488Hotdog Patient Warming SystemAugustine Biomedical & Design, LLC2011—
+1K202197Astopad Patient Warming SystemStihler Electronic GmbH2020—
+1K132048Barrier Easywarm Active Self-Warming BlanketMolnlycke Health Care Us, LLC2013—
+2K260278ThermAffyx (TM) Patient Safety SystemStihler Electronic GmbH2026—
+2K260903Hot Pink Pad Warming SystemXodus Medical, Inc.2026—
+2K232508Barrier EasyWarm Active Self-Warming BlanketMolnlycke Health Care Us, LLC2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
202020
202310
202620
FIG. 1 — Lineage of K112488, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K052392Hot Dog Patient Warming System
Summary page 1
…UXXX Product Code DWJ (21 CFR Part 870.5900), Common Name Thermal Regulating System Predicate Device HotDog Patient Warming System K052392 Device The HotDog Patient Warming System consists of a temperature control Description unit tha…
Augustine Biomedical & Design, LLC2006—

Also cleared against K052392: 4 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K202197Astopad Patient Warming SystemStihler Electronic GmbH20202
K132048Barrier Easywarm Active Self-Warming BlanketMolnlycke Health Care Us, LLC20131
K200446STERIS Patient Warming SystemSTERIS Corporation20200

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?

  • The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K202197 (Stihler Electronic GmbH, 2020) has gone furthest, with 2 descendants of its own.
  • 4 other devices also cite its predicate K052392.

How does its category compare?

All DWJ devices

DWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

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 HotDog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The HotDog Patient Warming System should be used in circumstances in which patients may not maintain a state of normothermia. The patient warming system can be used with adult and pediatric patients.

The System is intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms and on medical/surgical floors.

Indications for use as stated in the FDA summary.

Also cleared against K052392

4 other devices cite the same predicate.

  • K201779HotDog Temperature Management ControllerAugustine Temperature Management · 20204 recalls
  • K093244Unique Temp Warming Blankets, Model 8001140XXXGeratherm Medical AG · 2010
  • K094056Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC · 2010
  • K092807Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103Augustine Biomedical & Design, LLC · 2009

More from Augustine Biomedical & Design, LLC

4 FDA decisions under this applicant name. See the company

  • K094056Hotdog Multi Function ControllerAugustine Biomedical & Design, LLC · 2010
  • K092807Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103Augustine Biomedical & Design, LLC · 2009
  • K052392Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC · 2006

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/K112488 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112488: Hotdog Patient Warming System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112488

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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