510(k) Report

510(k) · Cleared

Recalled · 2009

Warm Air Warming Unit

K942599510(k) TraditionalCleared Jan 24, 1995237-day reviewClass II21 CFR 870.5900Recalls 3

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 Jan 24, 1995 after a 237-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 3 times.

Decided
Jan 24, 1995
Review
237 days
Class
Class II
Product code
DWJ
Recalls
3
Predicates
0

6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2010: 2 descendants cleared2012: 1 descendant cleared2013: 1 descendant cleared2017: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK942599 Warm Air Warming UnitCincinnati Sub-Zero Products, Inc. · 1995
  2. Descendant · cites it directly · 2 of its ownK101148 Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc. · 2010 · Recalled
  3. Descendant · cites it directly · 2 of its ownK101705 Mistral-Air Warming SystemThe Surgical Company International B.V. · 2010 · Recalled
  4. Descendant · 2 generations on · 1 of its ownK171234 Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company) · 2017
  5. Descendant · 2 generations on · 1 of its ownK121669 Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc. · 2012
  6. Descendant · 3 generations on · 0 of its ownK261437 Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2010: 22012: 12013: 12017: 12026: 1
2010high 2 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 6 · See all
  • K101148Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc. · 2010 · cites it directly2descendants
  • K101705Mistral-Air Warming SystemThe Surgical Company International B.V. · 2010 · cites it directly2descendants
  • K171234Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company) · 2017 · 2 generations on1descendant
  • K121669Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc. · 2012 · 2 generations on1descendant
  • K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K942599Warm Air Warming UnitCincinnati Sub-Zero Products, Inc.1995—
+1K101148Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc.20102
+1K101705Mistral-Air Warming SystemThe Surgical Company International B.V.20101
+2K171234Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company)2017—
+2K121669Warmair Model 135 Hyperthermia System (Controller and Blankets)Cincinnati Sub-Zero Products, Inc.2012—
+3K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201210
201310
201710
202610
FIG. 1 — Lineage of K942599, 1995–2026Source: 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? (6)

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

NumberDeviceApplicantDecidedDescendants
K101148Warm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc.20102
K101705Mistral-Air Warming SystemThe Surgical Company International B.V.20102

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 14, 2009Not classifiedZ-0781-2010OtherProduct is labeled as "Sterile". It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be assured.
Feb 16, 2009Not classifiedZ-0035-2010Process controlThe blower on the WarmAir 135 Warming Unit may overheat. Resistance in a connector between circuit board and wiring harness results in excessive heat that may melt connector or deform the outer casing of the blower unit.
Nov 5, 2004Not classifiedZ-0374-05OtherBurning smell, burned microprocessor board. The firm is modifying the connectors and wiring gauge configuration of the device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K101148 (Cincinnati Sub-Zero Products, Inc., 2010) has gone furthest, with 2 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 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/K942599 · printed Nov 6, 2026

Cite this page

510(k) Report. “K942599: Warm Air Warming Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942599

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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