510(k) · Cleared
ClearedThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smisson-Cartledge Biomedical, LLC · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Aug 12, 2022 as substantially equivalent to K052055 (Smisson-Cartledge Biomedical, LLC, 2006) after a 715-day review. Its family tree reaches back 5 generations to 1985. 1 of the 8 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 12, 2022
- Review
- 715 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K852645 (1985). 7 ancestors in all. No later device cites it as a predicate yet. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK852645 Fluid Management SystemHaemonetics Corp. · 1985
- 4 generations backK972284 Fluid Management SystemBelmont Instrument Corp. · 1997 · Recalled
- 3 generations backK992672 Belmont Fluid Management System (FMS2000)Belmont Instrument Corp. · 1999
- 2 generations backK032778 Large Volume Fluid ReservoirBelmont Instrument Corp. · 2003
- 1 generation backK052055 Smisson-Cartledge Thermal Infusion System, Model Tis-1200Smisson-Cartledge Biomedical, LLC · 2006 · Recalled (Class I)
- This deviceK202461 ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal…Smisson-Cartledge Biomedical, LLC · 2022
Class I recalls in this family
- K052055 Smisson-Cartledge Thermal Infusion System, Model…direct predicate · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K852645 | Fluid Management System | Haemonetics Corp. | 1985 | — |
| −4 | K972284 | Fluid Management System | Belmont Instrument Corp. | 1997 | 1 |
| −3 | K992672 | Belmont Fluid Management System (FMS2000) | Belmont Instrument Corp. | 1999 | — |
| −2 | K032778 | Large Volume Fluid Reservoir | Belmont Instrument Corp. | 2003 | — |
| −1 | K052055 | Smisson-Cartledge Thermal Infusion System, Model Tis-1200 | Smisson-Cartledge Biomedical, LLC | 2006 | Class I |
| 0 (this device) | K202461 | ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion… | Smisson-Cartledge Biomedical, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 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.
1 device in this family has a Class I recall. 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 LGZ device
- #1 K260988 °M Warmer System with °M Stationscore 12.7 · 6 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 |
|---|---|---|---|
| * | K052055 | Smisson-Cartledge Thermal Infusion System, Model Tis-1200Summary page 4…the current “trade/proprietary name” for Smisson-Cartledge Biomedical TIS-1200 Thermal Infusion System, which was the name used within the prior 510(k) # K052055. Legally Marketed Predicate Device: Smisson-Cartledge Biomedical TIS-1200 Thermal Infusion System - 510(k) # K052055 Reason for… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K052055Smisson-Cartledge Thermal Infusion System, Model Tis-1200Smisson-Cartledge Biomedical, LLC · 2006 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · LGZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LGZ
546in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LGZ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LGZ
376in 2025
MAUDE reports naming product code LGZ, 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 | 2 | — | 0 | 11 |
| 2008 | 4 | 99 | 0 | 10 |
| 2009 | 2 | — | 1 | 12 |
| 2010 | 2 | — | 1 | 43 |
| 2011 | 3 | 77 | 8 | 54 |
| 2012 | 7 | 162 | 0 | 52 |
| 2013 | 5 | 143 | 0 | 16 |
| 2014 | 0 | — | 0 | 23 |
| 2015 | 2 | — | 1 | 34 |
| 2016 | 2 | — | 1 | 15 |
| 2017 | 2 | — | 0 | 58 |
| 2018 | 1 | — | 0 | 94 |
| 2019 | 3 | 209 | 0 | 340 |
| 2020 | 0 | — | 0 | 1,221 |
| 2021 | 0 | — | 0 | 885 |
| 2022 | 3 | 546 | 0 | 1,548 |
| 2023 | 1 | — | 0 | 1,033 |
| 2024 | 1 | — | 0 | 862 |
| 2025 | 2 | — | 0 | 376 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Smisson-Cartledge Biomedical ThermaCor® 1200 Rapid Thermal Infusion System is indicated for use over a full range of flow rates from slow feed to rapid, high flow infusion of: crystalloid, colloid, or blood product, including packed red blood cells [not in additive solutions and stored up to 21 days with anticoagulants], as volume replacement for patients suffering from blood loss due to trauma or surgery; warmed fluid to rewarm patients after surgery or for hypothermia; warmed fluid for irrigation in urology procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202461: ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202461
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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