Product code DWJ
- Device name
- System, Thermal Regulating
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.5900
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Definition
- 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).
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260903 | Hot Pink Pad Warming System | Xodus Medical, Inc. | 2026-04-16 |
| K252861 | Warming System | Hangzhou Tappa Medical Technology Co., Ltd. | 2026-04-07 |
| K251974 | Arctic Sun Temperature Management System (Model 5000) | Medivance, Inc. | 2025-10-24 |
| K242964 | Celsi Warmer | Hadleigh Health Technologies | 2025-06-20 |
| K243942 | Arctic Sun Stat Temperature Management System | Medivance, Inc. | 2025-04-30 |
| K232627 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | 2024-04-18 |
| K232502 | Cocoon Convective Warming System, Model CWS7000 | Care Essentials Pty, Ltd. | 2024-02-21 |
| K231211 | Medline ComfortTemp Patient Warming System | Medline Industries, LP | 2023-12-01 |
| K232638 | FilteredFlo Warming Blankets | Iob Medical, Inc. | 2023-10-24 |
| K232844 | The IQoolTM System | Braincool AB | 2023-10-04 |
| K232508 | Barrier EasyWarm Active Self-Warming Blanket | Molnlycke Health Care Us, LLC | 2023-09-15 |
| K231596 | IOB Temperature Management System | Iob Medical, Inc. | 2023-06-30 |
| K230866 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | 2023-06-29 |
| K221669 | IOB Warming Blankets | Iob Medical, Inc. | 2022-12-27 |
| K220941 | HotDog Temperature Management System | Augustine Temperature Management | 2022-09-23 |
| K210605 | 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation | 3M Company | 2021-04-29 |
| K210603 | 3M Bair Hugger Temperature Management System (Model 675) | 3M Company | 2021-03-30 |
| K203085 | NOVA Patient Warming System | Encompass Group, LLC | 2020-11-12 |
| K201779 | HotDog Temperature Management Controller | Augustine Temperature Management | 2020-09-11 |
| K202197 | Astopad Patient Warming System | Stihler Electronic GmbH | 2020-09-04 |
| K200446 | STERIS Patient Warming System | STERIS Corporation | 2020-06-13 |
| K200225 | Arctic Sun Stat Temperature Management System | Medivance, Inc. | 2020-02-28 |
| K190221 | IOB Warming Blankets | Iob Medical, Inc. | 2019-10-25 |
| K181671 | Cocoon Convective Warming System | Care Essentials Pty, Ltd. | 2019-05-02 |
| K180834 | Altrix Precision Temperature Management System | Stryker Medical | 2018-08-10 |
| K181699 | Level 1 Convective Warmer | Smiths Medical Asd, Inc. | 2018-07-26 |
| K180375 | The IQoolTM Warm System | Braincool AB | 2018-05-18 |
| K171373 | 3M Bair Hugger Model 675 Total Temperature Management System | 3M Company | 2017-10-10 |
| K171149 | Altrix Temperature Management Wraps | Stryker Medical | 2017-07-18 |
| K171234 | Mistral-Air Warming Unit | The Surgical Company International BV (As the 37company) | 2017-05-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327374155 | Altrix Temperature Management Wraps | STRYKER CORPORATION | 2018-07-31 |
| 07613327374148 | Altrix Temperature Management Wraps | STRYKER CORPORATION | 2018-07-31 |
| 07613327374131 | Altrix Temperature Management Wraps | STRYKER CORPORATION | 2018-07-31 |
| 07613327374124 | Altrix Temperature Management Wraps | STRYKER CORPORATION | 2018-07-31 |
| 07613327374117 | Altrix Temperature Management Wraps | STRYKER CORPORATION | 2018-07-31 |
| 07613327374100 | Altrix Temperature Management Wraps | STRYKER CORPORATION | 2018-07-31 |
| 07613327374094 | Altrix Temperature Management Wraps | STRYKER CORPORATION | 2018-07-31 |
| 07613327374087 | Altrix Temperature Management Wraps | STRYKER CORPORATION | 2018-07-31 |
| ET37MA5250PM0 | Mistral-Air | The Surgical Company International B.V. | 2017-08-07 |
| 07613327261417 | Rapr-Round | STRYKER CORPORATION | 2016-12-16 |
| 07613327261400 | Rapr Round | STRYKER CORPORATION | 2016-12-16 |
| 07613327261394 | Rapr Round | STRYKER CORPORATION | 2016-12-16 |
| 07613327261387 | Rapr Round | STRYKER CORPORATION | 2016-12-16 |
| 07613327261349 | Rapr Round | STRYKER CORPORATION | 2016-12-16 |
| ET37MA3330PM0 | Mistral-Air | The Surgical Company International B.V. | 2016-11-16 |
| ET37MA3365PM0 | Mistral-Air | The Surgical Company International B.V. | 2016-11-16 |
| ET37MA3360PM0 | Mistral-Air | The Surgical Company International B.V. | 2016-11-16 |
| ET37MA3350PM0 | Mistral-Air | The Surgical Company International B.V. | 2016-11-16 |
| ET37MA3340PM0 | Mistral-Air | The Surgical Company International B.V. | 2016-11-16 |
| ET37MA3320PM0 | Mistral Air | The Surgical Company International B.V. | 2016-11-16 |
| 07613327175158 | Rapr-Round | STRYKER CORPORATION | 2016-09-24 |
| 07613327175356 | Mul-T-Blanket | STRYKER CORPORATION | 2016-09-24 |
| 07613327175134 | Rapr-Round | STRYKER CORPORATION | 2016-09-24 |
| 07613327175127 | Mul-T-Blanket | STRYKER CORPORATION | 2016-09-24 |
| 07613327175103 | Rapr-Round | STRYKER CORPORATION | 2016-09-24 |
| 07613327175080 | Rapr-Round | STRYKER CORPORATION | 2016-09-24 |
| 07613327175073 | Rapr-Round | STRYKER CORPORATION | 2016-09-24 |
| 07613327175066 | Mul-T-Blanket | STRYKER CORPORATION | 2016-09-24 |
| 07613327175059 | Mul-T-Blanket | STRYKER CORPORATION | 2016-09-24 |
| 07613327169324 | NA | STRYKER CORPORATION | 2016-09-24 |