510(k) · Cleared
Recalled · Class II · 2018Altrix Precision Temperature Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Medical · DWJ System, Thermal Regulating
Cleared on Dec 2, 2016 as substantially equivalent to K100585 (Gaymar Industries, Inc., 2011) after a 479-day review. Its family tree reaches back 4 generations to 1991. 3 later devices descend from it. It has been recalled once.
- Decided
- Dec 2, 2016
- Review
- 479 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K912051 (1991). 10 ancestors in all, the oldest K811742 (1981). 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK912051 Medi-Therm (Mta-5900) & Detachable HosesGaymar Industries, Inc. · 1991 · Recalled
- 3 generations backK061023 Thermosuit SystemLife Recovery Systems Hd, LLC · 2006 · Recalled
- 2 generations backK070112 Rapidcool Patient Temperature Management SystemMedcool, Inc. · 2007
- 1 generation backK100585 Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc. · 2011
- This deviceK152266 Altrix Precision Temperature Management SystemStryker Medical · 2016
- Descendant · cites it directly · 0 of its ownK242964 Celsi WarmerHadleigh Health Technologies · 2025
- Descendant · cites it directly · 0 of its ownK180834 Altrix Precision Temperature Management SystemStryker Medical · 2018 · Recalled
- Descendant · cites it directly · 0 of its ownK171149 Altrix Temperature Management WrapsStryker Medical · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912051 | Medi-Therm (Mta-5900) & Detachable Hoses | Gaymar Industries, Inc. | 1991 | 2 |
| −3 | K061023 | Thermosuit System | Life Recovery Systems Hd, LLC | 2006 | 1 |
| −2 | K070112 | Rapidcool Patient Temperature Management System | Medcool, Inc. | 2007 | — |
| −1 | K100585 | Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900 | Gaymar Industries, Inc. | 2011 | — |
| 0 (this device) | K152266 | Altrix Precision Temperature Management System | Stryker Medical | 2016 | — |
| +1 | K242964 | Celsi Warmer | Hadleigh Health Technologies | 2025 | — |
| +1 | K180834 | Altrix Precision Temperature Management System | Stryker Medical | 2018 | 1 |
| +1 | K171149 | Altrix Temperature Management Wraps | Stryker Medical | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K100585 | Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Summary page 4…Predicate Device Stryker Medical claims substantial equivalence to Stryker Medical (previously Gaymar Industries Inc.) Medi-Therm Hyper/Hypothermia System cleared per K100585. Altrix - Summary Statement Page 1 of 7… | 2011 |
What descends from it? (3)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 6, 2018 | Class II | Z-0235-2019 | Software design | Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5C while in Automatic mode. 2. Users may experience a Remove from Use code 9 (RFU 9) fault condition relating to inadvertent… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 7 of the 10 ancestors have a recall of any class.
- Of its descendants, K242964 (Hadleigh Health Technologies, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K100585.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician or clinician with prescription privileges determines that temperature therapy is necessary or desirable. Indications for use for the Altrix system include: a. Maintain pre-set body temperature as determined by the physician b. Maintain…
Read the full statement (115 words)
The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician or clinician with prescription privileges determines that temperature therapy is necessary or desirable.
Indications for use for the Altrix system include:
a. Maintain pre-set body temperature as determined by the physician
b. Maintain normal body temperature during surgical procedures
c. For use in all clinical settings including coronary care units, operating, recovery and emergency departments, burn units, and medical/surgical units
d. Adult and pediatric patients
e. Monitoring and controlling patient temperature
f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152266: Altrix Precision Temperature Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152266
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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