510(k) · Cleared
Recalled · Class II · 2018Pintler Patient Warming System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pintler Medical · DWJ System, Thermal Regulating
Cleared on Aug 31, 2012 as substantially equivalent to K062794 (American Healthcare Products, Inc., 2006) after a 259-day review. Its family tree reaches back 3 generations to 2000. It has been recalled once.
- Decided
- Aug 31, 2012
- Review
- 259 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002577 (2000). 5 ancestors in all, the oldest K001149 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK002577 Arctic Sun Temperature Management System, Model 100 Control Unit and…Medivance, Inc. · 2000 · Recalled
- 2 generations backK033021 Kimberly-Clark Patient Warming System - Model 100 Control Unit and…Kimberly-Clark Corp. · 2003 · Recalled
- 1 generation backK062794 PRN Thermalcare, Model 3000American Healthcare Products, Inc. · 2006
- This deviceK113705 Pintler Patient Warming SystemPintler Medical · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002577 | Arctic Sun Temperature Management System, Model 100 Control Unit and Patient… | Medivance, Inc. | 2000 | 1 |
| −2 | K033021 | Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy… | Kimberly-Clark Corp. | 2003 | 2 |
| −1 | K062794 | PRN Thermalcare, Model 3000 | American Healthcare Products, Inc. | 2006 | — |
| 0 (this device) | K113705 | Pintler Patient Warming System | Pintler Medical | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K062794 | PRN Thermalcare, Model 3000Summary page 1…uivalent: The Pintler Patient Warming System is substantially equivalent to the following devices: PRN ThermalCare 3000 Control Unit and Power Also known as PerfecTemp K062794 Description of the Device: The Pintler Patient Warming System a thermal regulating operating room pad, and a power control unit… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 20, 2018 | Class II | Z-1139-2019 | Nonconforming Material/Component | Malfunction warming pad. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K062794.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 Pintler Patient Warming System aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113705 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113705: Pintler Patient Warming System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113705
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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