510(k) · Cleared
Recalled · Class II · 2017Medi-Therm (Mta-5900) & Detachable Hoses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gaymar Industries, Inc. · DWJ System, Thermal Regulating
Cleared on Jul 30, 1991 after an 82-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 46 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 30, 1991
- Review
- 82 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- 2
- Predicates
- 0
46 later devices descend from it, 5 citing it directly.
- This deviceK912051 Medi-Therm (Mta-5900) & Detachable HosesGaymar Industries, Inc. · 1991
- Descendant · cites it directly · 20 of its ownK071341 Modification to Arctic Sun Temperature Management System, Model 2000Medivance, Inc. · 2007 · Recalled
- Descendant · cites it directly · 18 of its ownK061023 Thermosuit SystemLife Recovery Systems Hd, LLC · 2006 · Recalled
- Descendant · 2 generations on · 16 of its ownK083662 CriticoolMtre Advanced Technology, Ltd. · 2009 · Recalled
- Descendant · cites it directly · 16 of its ownK022366 Celsius Control SystemInnercool Therapies · 2003
- Descendant · 2 generations on · 15 of its ownK030421 Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · Recalled
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K071341Modification to Arctic Sun Temperature Management System, Model 2000Medivance, Inc. · 2007 · cites it directly20descendants
- K061023Thermosuit SystemLife Recovery Systems Hd, LLC · 2006 · cites it directly18descendants
- K083662CriticoolMtre Advanced Technology, Ltd. · 2009 · 2 generations on16descendants
- K022366Celsius Control SystemInnercool Therapies · 2003 · cites it directly16descendants
- K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912051 | Medi-Therm (Mta-5900) & Detachable Hoses | Gaymar Industries, Inc. | 1991 | — |
| +1 | K071341 | Modification to Arctic Sun Temperature Management System, Model 2000 | Medivance, Inc. | 2007 | 1 |
| +1 | K061023 | Thermosuit System | Life Recovery Systems Hd, LLC | 2006 | 1 |
| +2 | K083662 | Criticool | Mtre Advanced Technology, Ltd. | 2009 | 1 |
| +1 | K022366 | Celsius Control System | Innercool Therapies | 2003 | — |
| +2 | K030421 | Alsius Coolgard 3000 & Alsius Catheter System | Alsius Corp. | 2003 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (46)
See all 465 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071341 | Modification to Arctic Sun Temperature Management System, Model 2000 | 2007 | 20 |
| K061023 | Thermosuit System | 2006 | 18 |
| K022366 | Celsius Control System | 2003 | 16 |
| K100585 | Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900 | 2011 | 9 |
| K101589 | Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems | 2010 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 29, 2017 | Class II | Z-2058-2017 | Software design | The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to view water temperature, and then switched back to "Automatic" mode. |
| Dec 27, 2013 | Class II | Z-0933-2014 | Device Design | Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature display while the unit is in Auto mode. While in Auto mode, only the patient temperature is displayed along with the set point. The… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071341 (Medivance, Inc., 2007) has gone furthest, with 20 descendants of its own.
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 | — |
https://510kreport.com/device/K912051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912051: Medi-Therm (Mta-5900) & Detachable Hoses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912051
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026