510(k) · Cleared
ClearedPRN Thermalcare, Model 3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Healthcare Products, Inc. · DWJ System, Thermal Regulating
Cleared on Dec 7, 2006 as substantially equivalent to K011859 (Klimamed Technologie Medizingerate GmbH, 2002) and 2 other predicates after an 80-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Dec 7, 2006
- Review
- 80 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002577 (2000). 4 ancestors in all, the oldest K001149 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002577 Arctic Sun Temperature Management System, Model 100 Control Unit and…Medivance, Inc. · 2000 · Recalled
- 1 generation backK033021 Kimberly-Clark Patient Warming System - Model 100 Control Unit and…Kimberly-Clark Corp. · 2003 · Recalled
- This deviceK062794 PRN Thermalcare, Model 3000American Healthcare Products, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK113705 Pintler Patient Warming SystemPintler Medical · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK080763 Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700…Talley Medical · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002577 | Arctic Sun Temperature Management System, Model 100 Control Unit and Patient… | Medivance, Inc. | 2000 | 1 |
| −1 | K033021 | Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy… | Kimberly-Clark Corp. | 2003 | 2 |
| 0 (this device) | K062794 | PRN Thermalcare, Model 3000 | American Healthcare Products, Inc. | 2006 | — |
| +1 | K113705 | Pintler Patient Warming System | Pintler Medical | 2012 | 1 |
| +1 | K080763 | Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700 HT | Talley Medical | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K011859 | Klimamed Thermal Mat & Controller 95 and 55 WattsSummary page 1…rming System &55 Temperature Model 100 Control unit and Management System Energy Transfer Pads K011859 K001149 K033021 Description of theDevice: The PRN ThennalCare patient warming system, Mode… | 2002 |
| * | K001149 | Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750…Summary page 1…Temperature Model 100 Control unit and Management System Energy Transfer Pads K011859 K001149 K033021 Description of theDevice: The PRN ThennalCare patient warming system, Model 3000 system includes a… | 2000 |
| * | K033021 | Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer PadsSummary page 1…Model 100 Control unit and Management System Energy Transfer Pads K011859 K001149 K033021 Description of theDevice: The PRN ThennalCare patient warming system, Model 3000 system includes a pressure reducing, thermal re… | 2003 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K113705 (Pintler Medical, 2012) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K011859.
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 PRN ThermalCare patient warming system is intended to aid in the maintenance of patient normal thermia (maintaining normal body temperature of 36C) before, during and after the perioperative experience (surgery) for Pediatric and Adult patients. Conductive warming temperatures for the patient are selected by physicians (anesthesiologist or nurse anesthetist) or according to facility hypothermia protocol. Pressure reduction is achieved within the pad design. The pressure reducing properties are effective for Patients up to 500 lbs./225k
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062794: PRN Thermalcare, Model 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062794
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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