510(k) Report

510(k) · Cleared

Recalled · 2011

Hemotherm Model 400

K811742510(k) TraditionalCleared Aug 13, 198155-day reviewClass II21 CFR 870.5900Recalls 2

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

Cincinnati Sub-Zero · DWJ System, Thermal Regulating

Cleared on Aug 13, 1981 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 55 later devices descend from it. It has been recalled 2 times.

Decided
Aug 13, 1981
Review
55 days
Class
Class II
Product code
DWJ
Recalls
2
Predicates
0

55 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2007: 5 descendants cleared2012: 3 descendants cleared2002: 1 descendant cleared2006: 1 descendant cleared2003: 4 descendants cleared2004: 2 descendants cleared2020: 3 descendants cleared2014: 5 descendants cleared2022: 3 descendants cleared2011: 3 descendants cleared2010: 4 descendants cleared2009: 2 descendants cleared2008: 3 descendants cleared2005: 2 descendants cleared2016: 4 descendants cleared2018: 2 descendants cleared2017: 1 descendant cleared2025: 3 descendants cleared2023: 2 descendants cleared2015: 1 descendant cleared2021: 1 descendant cleared19801990200020102020
  1. This deviceK811742 Hemotherm Model 400Cincinnati Sub-Zero · 1981
  2. Descendant · cites it directly · 27 of its ownK012512 Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002
  3. Descendant · cites it directly · 20 of its ownK071341 Modification to Arctic Sun Temperature Management System, Model 2000Medivance, Inc. · 2007 · Recalled
  4. Descendant · 2 generations on · 16 of its ownK083662 CriticoolMtre Advanced Technology, Ltd. · 2009 · Recalled
  5. Descendant · 2 generations on · 16 of its ownK022366 Celsius Control SystemInnercool Therapies · 2003
  6. Descendant · 2 generations on · 15 of its ownK030421 Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · Recalled

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

2002: 12003: 42004: 22005: 22006: 12007: 52008: 32009: 22010: 42011: 32012: 32014: 52015: 12016: 42017: 12018: 22020: 32021: 12022: 32023: 22025: 3
2002high 5 (2007) · low 0 (2013)2026

Most influential descendants

Showing 5 of 55 · See all
  • K012512Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002 · cites it directly27descendants
  • K071341Modification to Arctic Sun Temperature Management System, Model 2000Medivance, Inc. · 2007 · cites it directly20descendants
  • K083662CriticoolMtre Advanced Technology, Ltd. · 2009 · 2 generations on16descendants
  • K022366Celsius Control SystemInnercool Therapies · 2003 · 2 generations on16descendants
  • K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · 2 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K811742Hemotherm Model 400Cincinnati Sub-Zero1981—
+1K012512Setpoint Endovascular Temperature Management SystemRadiant Medical2002—
+1K071341Modification to Arctic Sun Temperature Management System, Model 2000Medivance, Inc.20071
+2K083662CriticoolMtre Advanced Technology, Ltd.20091
+2K022366Celsius Control SystemInnercool Therapies2003—
+2K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp.20034

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200340
200420
200520
200610
200750
200830
200920
201040
201130
201230
201450
201510
201640
201710
201820
202030
202110
202230
202320
202530
FIG. 1 — Lineage of K811742, 1981–2025Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (55)

See all 55

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

NumberDeviceApplicantDecidedDescendants
K012512Setpoint Endovascular Temperature Management SystemRadiant Medical200227
K071341Modification to Arctic Sun Temperature Management System, Model 2000Medivance, Inc.200720
K070112Rapidcool Patient Temperature Management SystemMedcool, Inc.200711
K052601Stockert Heater-Cooler System 3TSorin Group Deutschland GmbH20064
K122813Hemotherm Model 400CE Cooler/Heater SystemCincinnati Sub-Zero Products, Inc.20120

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

Recalls of this device

DateClassRecallRoot causeReason
May 2, 2011Not classifiedZ-2720-2011Device DesignThe probe jack contacts (terminals) on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. If this situation…
May 2, 2011Not classifiedZ-2721-2011Device DesignThe probe jack contacts (terminals) on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. If this situation…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K012512 (Radiant Medical, 2002) has gone furthest, with 27 descendants of its own.

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—

More from Cincinnati Sub-Zero

2 FDA decisions under this applicant name. See the company

  • K811743MaxithermCincinnati Sub-Zero · 1981

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The DWJ category page

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https://510kreport.com/device/K811742 · printed Nov 6, 2026

Cite this page

510(k) Report. “K811742: Hemotherm Model 400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K811742

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026