510(k) · Cleared
ClearedTablegard Pressure Relieving Patient Warming Mattress, Model: TG 700 HT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Talley Medical · DWJ System, Thermal Regulating
Cleared on May 30, 2008 as substantially equivalent to K011859 (Klimamed Technologie Medizingerate GmbH, 2002) and 3 other predicates after a 73-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- May 30, 2008
- Review
- 73 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K011859 (2002). 7 ancestors in all, the oldest K001149 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK011859 Klimamed Thermal Mat & Controller 95 and 55 WattsKlimamed Technologie Medizingerate GmbH · 2002
- 2 generations backK031728 Klimamed Thermal Blankets, Including Arm Shoulder West Thermal…Klimamed Technologie Medizingerate GmbH · 2004
- 1 generation backK051419 Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1…Inditherm Medical · 2006
- This deviceK080763 Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700…Talley Medical · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011859 | Klimamed Thermal Mat & Controller 95 and 55 Watts | Klimamed Technologie Medizingerate GmbH | 2002 | — |
| −2 | K031728 | Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg… | Klimamed Technologie Medizingerate GmbH | 2004 | — |
| −1 | K051419 | Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1 | Inditherm Medical | 2006 | — |
| 0 (this device) | 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 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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? (4)
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 Watts | 2002 |
| * | K001149 | Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750… | 2000 |
| * | K062794 | PRN Thermalcare, Model 3000Summary page 1…evices E. KO 11859 Klinamed Thermal Mat & Controller F. KO 01149 Bair Hugger Patient Warming System G. KO 062794 PRN ThermalCare Patient Warming System H. KO 501419 Inditherm Patient Warming System Description of the T… | 2006 |
| * | K051419 | Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1 | 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)
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 2.1 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 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. 2008, 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?
Use of the Talley TableGard Pressure Relieving Patient Warming Mattress is indicated for use for patients that may be benefited by the application of heat during surgical procedures to help maintain normothermia. It is intended for use in the operating rooms, recovery rooms, intensive care departments, emergency rooms in hospitals and outpatient clinics to assist patients to maintain normal body temperature. The TableGard mattress also includes alternating air support to relieve pressure against soft tissues during prolonged periods of immobilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080763 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080763: Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700 HT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080763
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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