Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DWJ · Predicate Candidate Screening
160 FDA 510(k) clearances under this product code; the 50 most recent screened below.
106 daysmedian FDA review time
305 days90th percentile
160clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261437 | Mistral-Air® Warming System | The Surgical Company International B.V., doing business as TSC Life | 2026-08-07 | 99 | 0 |
| K260278 | ThermAffyx(TM) Patient Safety System | Stihler Electronic GmbH | 2026-07-08 | 160 | 0 |
| K260903 | Hot Pink Pad Warming System | Xodus Medical, Inc. | 2026-04-16 | 29 | 0 |
| K252861 | Warming System | Hangzhou Tappa Medical Technology Co., Ltd. | 2026-04-07 | 210 | 0 |
| K251974 | Arctic Sun Temperature Management System (Model 5000) | Medivance, Inc. | 2025-10-24 | 120 | 0 |
| K242964 | Celsi Warmer | Hadleigh Health Technologies | 2025-06-20 | 267 | 0 |
| K243942 | Arctic Sun Stat Temperature Management System | Medivance, Inc. | 2025-04-30 | 131 | 0 |
| K232627 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | 2024-04-18 | 233 | 0 |
| K232502 | Cocoon Convective Warming System, Model CWS7000 | Care Essentials Pty, Ltd. | 2024-02-21 | 187 | 0 |
| K231211 | Medline ComfortTemp Patient Warming System | Medline Industries, LP | 2023-12-01 | 217 | 0 |
| K232638 | FilteredFlo Warming Blankets | Iob Medical, Inc. | 2023-10-24 | 55 | 0 |
| K232844 | The IQoolTM System | Braincool AB | 2023-10-04 | 20 | 0 |
| K232508 | Barrier EasyWarm Active Self-Warming Blanket | Molnlycke Health Care Us, LLC | 2023-09-15 | 28 | 0 |
| K231596 | IOB Temperature Management System | Iob Medical, Inc. | 2023-06-30 | 29 | 0 |
| K230866 | HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC | 2023-06-29 | 92 | 4 |
| K221669 | IOB Warming Blankets | Iob Medical, Inc. | 2022-12-27 | 201 | 0 |
| K220941 | HotDog Temperature Management System | Augustine Temperature Management | 2022-09-23 | 176 | 4 |
| K210605 | 3M Bair Hugger Universal Warming Gown made with Thinsulate I | 3M Company | 2021-04-29 | 59 | 0 |
| K210603 | 3M Bair Hugger Temperature Management System (Model 675) | 3M Company | 2021-03-30 | 29 | 0 |
| K203085 | NOVA Patient Warming System | Encompass Group, LLC | 2020-11-12 | 30 | 0 |
| K201779 | HotDog Temperature Management Controller | Augustine Temperature Management | 2020-09-11 | 73 | 4 |
| K202197 | Astopad Patient Warming System | Stihler Electronic GmbH | 2020-09-04 | 30 | 0 |
| K200446 | STERIS Patient Warming System | STERIS Corporation | 2020-06-13 | 110 | 0 |
| K200225 | Arctic Sun Stat Temperature Management System | Medivance, Inc. | 2020-02-28 | 29 | 1 |
| K190221 | IOB Warming Blankets | Iob Medical, Inc. | 2019-10-25 | 262 | 0 |
| K181671 | Cocoon Convective Warming System | Care Essentials Pty, Ltd. | 2019-05-02 | 311 | 0 |
| K180834 | Altrix Precision Temperature Management System | Stryker Medical | 2018-08-10 | 133 | 0 |
| K181699 | Level 1 Convective Warmer | Smiths Medical Asd, Inc. | 2018-07-26 | 29 | 0 |
| K180375 | The IQoolTM Warm System | Braincool AB | 2018-05-18 | 95 | 0 |
| K171373 | 3M Bair Hugger Model 675 Total Temperature Management System | 3M Company | 2017-10-10 | 153 | 0 |
| K171149 | Altrix Temperature Management Wraps | Stryker Medical | 2017-07-18 | 90 | 0 |
| K171234 | Mistral-Air Warming Unit | The Surgical Company International BV (As the 37company) | 2017-05-26 | 29 | 0 |
| K162679 | IOB Temperature Management System | Iob Medical, Inc. | 2017-04-28 | 214 | 0 |
| K162562 | OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY | Bcg Medical, LLC | 2017-03-17 | 184 | 0 |
| K152266 | Altrix Precision Temperature Management System | Stryker Medical | 2016-12-02 | 479 | 0 |
| K161602 | Arctic Sun Temperature Management System | Medivance, Inc. | 2016-09-02 | 85 | 1 |
| K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Un | Medivance, Inc. | 2014-12-18 | 87 | 2 |
| K140078 | TECOTHERM NEO (T NEO) | Inspiration Healthcare, Ltd. | 2014-11-14 | 305 | 0 |
| K141686 | EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONV | Smith Medical Asd, Inc. | 2014-10-28 | 127 | 0 |
| K140635 | COCOON CONVECTIVE WARMING SYSTEM | Care Essentials Pty, Ltd. | 2014-07-25 | 135 | 0 |
| K132048 | BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET | Molnlycke Health Care Us, LLC | 2013-11-06 | 127 | 0 |
| K132454 | VITAHEAT PATIENT WARMING SYSTEM | Vitaheat Medical, LLC | 2013-10-04 | 59 | 0 |
| K131361 | WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET | Covidien | 2013-07-29 | 77 | 0 |
| K123083 | COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT | Covidien | 2013-04-17 | 198 | 0 |
| K123946 | WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO | Cincinnati Sub-Zero Products, Inc. | 2013-01-17 | 27 | 0 |
| K113705 | PINTLER PATIENT WARMING SYSTEM | Pintler Medical | 2012-08-31 | 259 | 0 |
| K121720 | WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM | Welkins, LLC | 2012-08-20 | 69 | 0 |
| K120849 | HYBRID ARCTICGEL PAD | Medivance, Inc. | 2012-07-20 | 122 | 0 |
| K121669 | WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKE | Cincinnati Sub-Zero Products, Inc. | 2012-07-03 | 27 | 0 |
| K120081 | NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS | Cincinnati Sub-Zero Products, Inc. | 2012-02-17 | 37 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda