510(k) · Cleared
Recalled · Class II · 2012Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corp. · DWJ System, Thermal Regulating
Cleared on Nov 12, 2003 as substantially equivalent to K002577 (Medivance, Inc., 2000) after a 47-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 12, 2003
- Review
- 47 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002577 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002577 Arctic Sun Temperature Management System, Model 100 Control Unit and…Medivance, Inc. · 2000 · Recalled
- This deviceK033021 Kimberly-Clark Patient Warming System - Model 100 Control Unit and…Kimberly-Clark Corp. · 2003
- Descendant · cites it directly · 2 of its ownK062794 PRN Thermalcare, Model 3000American Healthcare Products, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK113705 Pintler Patient Warming SystemPintler Medical · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK080763 Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700…Talley Medical · 2008
Most influential descendants
Showing 3 of 3 · See all- K062794PRN Thermalcare, Model 3000American Healthcare Products, Inc. · 2006 · cites it directly2descendants
- K113705Pintler Patient Warming SystemPintler Medical · 2012 · 2 generations on0descendants
- K080763Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700 HTTalley Medical · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002577 | Arctic Sun Temperature Management System, Model 100 Control Unit and Patient… | Medivance, Inc. | 2000 | 1 |
| 0 (this device) | K033021 | Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy… | Kimberly-Clark Corp. | 2003 | — |
| +1 | K062794 | PRN Thermalcare, Model 3000 | American Healthcare Products, Inc. | 2006 | — |
| +2 | K113705 | Pintler Patient Warming System | Pintler Medical | 2012 | 1 |
| +2 | K080763 | Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700 HT | Talley Medical | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
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 K260278 ThermAffyx (TM) Patient Safety Systemscore 12.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002577 | Arctic Sun Temperature Management System, Model 100 Control Unit and Patient Energy…Summary page 1…lly equivalent to the MediVance Inc. ARTIC SUNTM Temperature Management System - Model 100 Control Unit and Energy Transfer Pads cleared under 51O(k) # K002577. 4. Intended Use of the Device The Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy… | 2000 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062794 | PRN Thermalcare, Model 3000 | 2006 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 27, 2012 | Class II | Z-2181-2012 | Device Design | A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to lose its ability to warm and maintain set temperature and may also result in excessive heat with the fuse assembly that could lead to the… |
| Sep 16, 2010 | Class II | Z-0451-2013 | Component design/selection | Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWJ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWJ
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWJ
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWJ
2,384in 2025
MAUDE reports naming product code DWJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 106 | 0 | 52 |
| 2008 | 3 | 73 | 0 | 40 |
| 2009 | 3 | 106 | 6 | 71 |
| 2010 | 8 | 134 | 2 | 104 |
| 2011 | 4 | 180 | 7 | 136 |
| 2012 | 5 | 69 | 1 | 106 |
| 2013 | 5 | 77 | 2 | 73 |
| 2014 | 4 | 131 | 0 | 116 |
| 2015 | 0 | — | 1 | 245 |
| 2016 | 2 | — | 0 | 1,400 |
| 2017 | 5 | 153 | 3 | 1,473 |
| 2018 | 3 | 95 | 5 | 1,517 |
| 2019 | 2 | — | 3 | 2,294 |
| 2020 | 5 | 30 | 2 | 2,546 |
| 2021 | 2 | — | 1 | 2,689 |
| 2022 | 2 | — | 5 | 3,226 |
| 2023 | 6 | 42 | 0 | 3,455 |
| 2024 | 2 | — | 3 | 3,329 |
| 2025 | 3 | 131 | 0 | 2,384 |
| 2026 | 5 | 99 | 3 | — |
What is it indicated for?
The KIMBERLY-CLARK* Patient Warming System is intended for monitoring and controlling patient temperature. The indications for use of the device include any condition where patient temperature control within the range covering mild hypothermia to normot6efmia is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033021: Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033021
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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