510(k) Report

510(k) · Cleared

Recalled · 2011

Warm Air Model 135 Hyperthermia System and Blankets

K101148510(k) TraditionalCleared Oct 1, 2010161-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 Products, Inc. · DWJ System, Thermal Regulating

Cleared on Oct 1, 2010 as substantially equivalent to K942599 (Cincinnati Sub-Zero Products, Inc., 1995) and 4 other predicates after a 161-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it. It has been recalled 2 times.

Decided
Oct 1, 2010
Review
161 days
Class
Class II
Product code
DWJ
Recalls
2
Predicates
5

Its longest line of descent runs back 2 generations to K904690 (1991). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1996: 1 other ancestor1995: 2 other ancestors2012: 1 descendant cleared2013: 1 descendant clearedK904690 · Temp Marq (TM) Convective Warming System · Marquest Medical Products, Inc. · 1991K011907 · Snuggle Warm 4000 Convective Warming System · Sims Level 1, Inc. · 2001 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 2 descendants K011907 · Snuggle Warm 4000 Convective Warming System · Sims Level 1, Inc. · 2001 · recalledK904690 · Temp Marq (TM) Convective Warming System · Marquest Medical Products, Inc. · 19910
  1. Root · 2 generations backK904690 Temp Marq (TM) Convective Warming SystemMarquest Medical Products, Inc. · 1991
  2. 1 generation backK011907 Snuggle Warm 4000 Convective Warming SystemSims Level 1, Inc. · 2001 · Recalled
  3. This deviceK101148 Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc. · 2010
  4. Descendant · cites it directly · 1 of its ownK121669 Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc. · 2012
  5. Descendant · cites it directly · 0 of its ownK123946 Warmair Model 135 Hyperthermia System Including Filteredflo BlanketsCincinnati Sub-Zero Products, Inc. · 2013

Most influential descendants

Showing 2 of 2 · See all
  • K121669Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc. · 2012 · cites it directly1descendant
  • K123946Warmair Model 135 Hyperthermia System Including Filteredflo BlanketsCincinnati Sub-Zero Products, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K904690Temp Marq (TM) Convective Warming SystemMarquest Medical Products, Inc.1991—
−1K011907Snuggle Warm 4000 Convective Warming SystemSims Level 1, Inc.20011
0 (this device)K101148Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc.2010—
+1K121669Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc.2012—
+1K123946Warmair Model 135 Hyperthermia System Including Filteredflo BlanketsCincinnati Sub-Zero Products, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
199610
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
FIG. 1 — Lineage of K101148, 1991–2013Source: 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? (5)

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
*K942599Warm Air Warming Unit
Summary page 1
…ATION: 21 CFR 870.5900 8. CLASSIFICATION PRODUCT CODE: DWJ 9. PANEL: Cardiovascular 10. DEVICE CLASSIFICATION: Class II II1. IDENTIFICATION OF PREDICATES: a. K942599 and K942790 Cincinnati Sub-Zero WarmAir Hyperthermia system Model 133 and blankets b. KOI1 1907 SIMS Level I S…
Cincinnati Sub-Zero Products, Inc.19953
*K942790Warm Air Hypertheermia System (Models #130 and #133)
Summary page 1
…R 870.5900 8. CLASSIFICATION PRODUCT CODE: DWJ 9. PANEL: Cardiovascular 10. DEVICE CLASSIFICATION: Class II II1. IDENTIFICATION OF PREDICATES: a. K942599 and K942790 Cincinnati Sub-Zero WarmAir Hyperthermia system Model 133 and blankets b. KOI1 1907 SIMS Level I Snuggle Warm…
Cincinnati Sub-Zero Products, Inc.1995—
*K011907Snuggle Warm 4000 Convective Warming SystemSims Level 1, Inc.20011
*K040632Snuggle Warm 4000 Convective Warming System, Model SW4000
Summary page 1
…nd blankets b. KOI1 1907 SIMS Level I Snuggle Warm 4000/Equator 5000 Convective Warming System and blanket (now sold by Smiths Medical ASD) c. K040632 Smiths Medical ASD Sterile Cardiac Blanket component of Snuggle Warm 4000 Convective Warming System d. K960 16…
Smiths Medical Asd, Inc.20041
*K960167System, Thermal Regulating 74-DWJ
Summary page 1
…sold by Smiths Medical ASD) c. K040632 Smiths Medical ASD Sterile Cardiac Blanket component of Snuggle Warm 4000 Convective Warming System d. K960 167 Bair Hugger Model 505 Total Temperature Management System R…
Augustine Medical, Inc.1996—

Also cleared against K942599: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K121669Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc.20121
K123946Warmair Model 135 Hyperthermia System Including Filteredflo BlanketsCincinnati Sub-Zero Products, Inc.20130

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

Recalls of this device

DateClassRecallRoot causeReason
Jul 20, 2011Not classifiedZ-3119-2011Labeling designCincinnati Sub-Zero is conducting a field correction due to changes that have been made to the WarmAir Model 135 devices Operation and Technical Manuals in order to comply with FDA device labeling regulations.
Jun 1, 2011Not classifiedZ-2888-2011Device DesignDue to its design the circuit breaker on the device could trip causing it to shut down and not provide heated air to the blanket.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
  • 3 of the 6 ancestors have a recall of any class.
  • Of its descendants, K121669 (Cincinnati Sub-Zero Products, Inc., 2012) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K942599.

How does its category compare?

All DWJ devices

DWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 WarmAir® 135 patient warming system is intended to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. The thermal regulating system is used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air-heated blanket. The single-patient use blankets transfer the thermal energy to adult, pediatric or neonate patients to obtain/maintain normal body temperature. It is intended for use by appropriately trained healthcare professionals in clinical environments.

Indications for use as stated in the FDA summary.

Also cleared against K942599

1 other device cites the same predicate.

  • K101705Mistral-Air Warming SystemThe Surgical Company International B.V. · 20101 recall

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
  • K120081Norm-O-Temp Hyperthermia System Incliding Blankets/PadsCincinnati Sub-Zero Products, Inc. · 20121 recall
  • K110104Blanketrol II Hyper-Hypothermia Temperature Managment SystemCincinnati Sub-Zero Products, Inc. · 20113 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/K101148 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101148: Warm Air Model 135 Hyperthermia System and Blankets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101148

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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