Warmair Model 135 Hyperthermia System Including Filteredflo Blankets
FDA 510(k) K123946 · Cincinnati Sub-Zero Products, Inc.
510(k) numberK123946
Submission
- Device name
- Warmair Model 135 Hyperthermia System Including Filteredflo Blankets
- Applicant
- Cincinnati Sub-Zero Products, Inc.
Sharonville, OH, US - Received
- December 21, 2012
- Decision date
- January 17, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWJ – System, Thermal Regulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5900
- Specialty
- Cardiovascular
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K262089 | Disposable Warming BlanketDWJ · Traditional | Hangzhou Tappa Medical Technology Co., Ltd. | 08/21/2026SE |
| K261437 | Mistral-Air® Warming SystemDWJ · Special | The Surgical Company International B.V., doing… | 08/07/2026SE |
| K260278 | ThermAffyx(TM) Patient Safety SystemDWJ · Traditional | Stihler Electronic GmbH | 07/08/2026SE |
| K260903 | Hot Pink Pad Warming SystemDWJ · Traditional | Xodus Medical, Inc. | 04/16/2026SE |
| K252861 | Warming SystemDWJ · Traditional | Hangzhou Tappa Medical Technology Co., Ltd. | 04/07/2026SE |
| K251974 | Arctic Sun Temperature Management System (Model 5000)DWJ · Traditional | Medivance, Inc. | 10/24/2025SE |
| K242964 | Celsi WarmerDWJ · Traditional | Hadleigh Health Technologies | 06/20/2025SE |
| K243942 | Arctic Sun Stat Temperature Management SystemDWJ · Traditional | Medivance, Inc. | 04/30/2025SE |
| K232627 | HotDog Warming Mattress + Return ElectrodeDWJ · Special | Augustine Temperature Management, LLC | 04/18/2024SE |
| K232502 | Cocoon Convective Warming System, Model CWS7000DWJ · Traditional | Care Essentials Pty, Ltd. | 02/21/2024SE |
More from Care Essentials Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K122813 | Hemotherm Model 400CE Cooler/Heater SystemDWC · Traditional | 12/18/2012SE |
| K121669 | Warmair Model 135 Hyperthermia System (Controller and Blankets)DWJ · Special | 07/03/2012SE |
| K120081 | Norm-O-Temp Hyperthermia System Incliding Blankets/PadsDWJ · Traditional | 02/17/2012SE |
| K110104 | Blanketrol II Hyper-Hypothermia Temperature Managment SystemDWJ · Traditional | 02/04/2011SE |
| K101148 | Warm Air Model 135 Hyperthermia System and BlanketsDWJ · Traditional | 10/01/2010SE |
| K101589 | Blanketrol III, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsDWJ · Traditional | 09/20/2010SE |
| K072621 | Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature SensorBZT · Traditional | 12/13/2007SE |
| K070339 | Disposable Temperature Probes/Sensors and Instrument CablesFLL · Traditional | 09/26/2007SE |
| K942790 | Warm Air Hypertheermia System (Models #130 and #133)DWJ · Traditional | 01/24/1995SE |
| K942599 | Warm Air Warming UnitDWJ · Traditional | 01/24/1995SE |
Questions and answers
When was Warmair Model 135 Hyperthermia System Including Filteredflo Blankets cleared by the FDA?
Warmair Model 135 Hyperthermia System Including Filteredflo Blankets (K123946) received a 510(k) decision of Substantially Equivalent on January 17, 2013, 27 days after the submission was received.
What is the product code of K123946?
The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.