510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Norm-O-Temp Hyperthermia System Incliding Blankets/Pads

K120081510(k) TraditionalCleared Feb 17, 201237-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

Cincinnati Sub-Zero Products, Inc. · DWJ System, Thermal Regulating

Cleared on Feb 17, 2012 as substantially equivalent to K881322 (Seabrook Medical Systems, Inc., 1988) and 2 other predicates after a 37-day review. Its family tree reaches back 4 generations to 2000. It has been recalled once.

Decided
Feb 17, 2012
Review
37 days
Class
Class II
Product code
DWJ
Recalls
1
Predicates
3

Its longest line of descent runs back 4 generations to K003349 (2000). 11 ancestors in all, the oldest K811742 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 2 other ancestors1988: 1 other ancestor1991: 2 other ancestors2007: 1 other ancestor1981: 1 other ancestorK003349 · Allon 2001 Modified · Mtre Advanced Technology, Ltd. · 2000K024128 · Allon 2001 Version 5 · Mtre Advanced Technology, Ltd. · 2003 · recalledK083662 · Criticool · Mtre Advanced Technology, Ltd. · 2009 · recalledK101589 · Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems · Cincinnati Sub-Zero Products, Inc. · 2010 · recalled1980198519901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor4 generations back: 2 other ancestors K101589 · Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems · Cincinnati Sub-Zero Products, Inc. · 2010 · recalledK083662 · Criticool · Mtre Advanced Technology, Ltd. · 2009 · recalledK024128 · Allon 2001 Version 5 · Mtre Advanced Technology, Ltd. · 2003 · recalledK003349 · Allon 2001 Modified · Mtre Advanced Technology, Ltd. · 20000
  1. Root · 4 generations backK003349 Allon 2001 ModifiedMtre Advanced Technology, Ltd. · 2000
  2. 3 generations backK024128 Allon 2001 Version 5Mtre Advanced Technology, Ltd. · 2003 · Recalled
  3. 2 generations backK083662 CriticoolMtre Advanced Technology, Ltd. · 2009 · Recalled
  4. 1 generation backK101589 Blanketrol Iii, Model 233 and Coolblue, Model 25-01…Cincinnati Sub-Zero Products, Inc. · 2010 · Recalled
  5. This deviceK120081 Norm-O-Temp Hyperthermia System Incliding Blankets/PadsCincinnati Sub-Zero Products, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K003349Allon 2001 ModifiedMtre Advanced Technology, Ltd.2000—
−3K024128Allon 2001 Version 5Mtre Advanced Technology, Ltd.20031
−2K083662CriticoolMtre Advanced Technology, Ltd.20091
−1K101589Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsCincinnati Sub-Zero Products, Inc.20106
0 (this device)K120081Norm-O-Temp Hyperthermia System Incliding Blankets/PadsCincinnati Sub-Zero Products, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198810
199120
200120
200710
FIG. 1 — Lineage of K120081, 2000–2012Source: 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? (3)

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
*K881322Mini-Temp (TM)
Our reading of the summary gave K881332, FDA’s number for Diaflex Grasp Forceps/Retrieval Loop & Cyto Brush (Baxter Healthcare Corp). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Seabrook Medical Systems Mini-Temp Hyperthermia system including…”.
Seabrook Medical Systems, Inc.1988—
*K101589Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsCincinnati Sub-Zero Products, Inc.20106
*K011907Snuggle Warm 4000 Convective Warming SystemSims Level 1, Inc.20011

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 20, 2019Class IIZ-2355-2019Labeling False and MisleadingThe manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
  • 8 of the 11 ancestors have a recall of any class.

How does its category compare?

All DWJ devices

DWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Norm-O-Temp® Model 11I1Z hyperthermia system is intended to prevent hypothermia during surgical procedures and to reduce cold discomfort before, during, and after a surgical procedure. The thermal regulating system is used to keep a patient comfortable by maintaining blanket/pad water temperature through conductive heat transfer. The water heated blankets transfer the thermal energy to adult, pediatric, and infant (includes neonates) patients to keep a patient at a comfortable temperature. The Norm-O-Temp system is composed of a heater, circulating pump, and blankets/pads. It is intended for use by appropriately trained healthcare professionals in clinical environments.

Indications for use as stated in the FDA summary.

More from Cincinnati Sub-Zero Products, Inc.

12 FDA decisions under this applicant name. See the company

  • K123946Warmair Model 135 Hyperthermia System Including Filteredflo BlanketsCincinnati Sub-Zero Products, Inc. · 2013
  • K122813Hemotherm Model 400CE Cooler/Heater SystemCincinnati Sub-Zero Products, Inc. · 20126 recalls
  • K121669Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc. · 2012
  • K110104Blanketrol II Hyper-Hypothermia Temperature Managment SystemCincinnati Sub-Zero Products, Inc. · 20113 recalls
  • K101148Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc. · 20102 recalls

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/K120081 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120081: Norm-O-Temp Hyperthermia System Incliding Blankets/Pads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120081

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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