510(k) · Cleared

Recalled · Class I · 2021

Smisson-Cartledge Thermal Infusion System, Model Tis-1200

K052055510(k) TraditionalCleared Oct 26, 2006454-day reviewClass II21 CFR 880.5725Recalls 3 (3 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smisson-Cartledge Biomedical, LLC · LGZ Warmer, Thermal, Infusion Fluid

Cleared on Oct 26, 2006 as substantially equivalent to K032778 (Belmont Instrument Corp., 2003) and 4 other predicates after a 454-day review. Its family tree reaches back 4 generations to 1985. 1 of the 8 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 3 times, including 3 Class I recalls.

Decided: Oct 26, 2006
Review: 454 days
Class: Class II
Product code: LGZ
Recalls: 3 (3 Class I)
Predicates: 6

Its longest line of descent runs back 4 generations to K852645 (1985). 6 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 4 generations backK852645 Fluid Management SystemHaemonetics Corp. · 1985
3 generations backK972284 Fluid Management SystemBelmont Instrument Corp. · 1997 · Recalled
2 generations backK992672 Belmont Fluid Management System (FMS2000)Belmont Instrument Corp. · 1999
1 generation backK032778 Large Volume Fluid ReservoirBelmont Instrument Corp. · 2003
This deviceK052055 Smisson-Cartledge Thermal Infusion System, Model Tis-1200Smisson-Cartledge Biomedical, LLC · 2006
Descendant · cites it directly · 0 of its ownK202461 ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal…Smisson-Cartledge Biomedical, LLC · 2022

Most influential descendants

Showing 1 of 1 · See all

K202461ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion SystemSmisson-Cartledge Biomedical, LLC · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K852645	Fluid Management System	Haemonetics Corp.	1985	—
−3	K972284	Fluid Management System	Belmont Instrument Corp.	1997	1
−2	K992672	Belmont Fluid Management System (FMS2000)	Belmont Instrument Corp.	1999	—
−1	K032778	Large Volume Fluid Reservoir	Belmont Instrument Corp.	2003	—
0 (this device)	K052055	Smisson-Cartledge Thermal Infusion System, Model Tis-1200	Smisson-Cartledge Biomedical, LLC	2006	—
+1	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0

FIG. 1 — Lineage of K052055, 1985–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K032778	Large Volume Fluid Reservoir Summary page 5 …Infusion Pump Product Code: LGZ; FRN; FPA Legally Marketed Predicate Device: Belmont Fluid Management System (FMS2000) - 510(k) # K032778, K032674, K992672, K983975, K972284 Smiths Level 1® H-1200 Fast Flow Fluid Warmer System - 510(k) # BK020043…	Belmont Instrument Corp.	2003	—
*	K032674	Belmont Fluid Management System, Model FMS2000 Summary page 5 …nfusion Pump Product Code: LGZ; FRN; FPA Legally Marketed Predicate Device: Belmont Fluid Management System (FMS2000) - 510(k) # K032778, K032674, K992672, K983975, K972284 Smiths Level 1® H-1200 Fast Flow Fluid Warmer System - 510(k) # BK020043 Device De…	Belmont Instrument Corp.	2003	1
*	K992672	Belmont Fluid Management System (FMS2000) Summary page 5 …ump Product Code: LGZ; FRN; FPA Legally Marketed Predicate Device: Belmont Fluid Management System (FMS2000) - 510(k) # K032778, K032674, K992672, K983975, K972284 Smiths Level 1® H-1200 Fast Flow Fluid Warmer System - 510(k) # BK020043 Device Description…	Belmont Instrument Corp.	1999	—
*	K983975	Belmont Fluid Management System (FMS2000) Summary page 5 …: LGZ; FRN; FPA Legally Marketed Predicate Device: Belmont Fluid Management System (FMS2000) - 510(k) # K032778, K032674, K992672, K983975, K972284 Smiths Level 1® H-1200 Fast Flow Fluid Warmer System - 510(k) # BK020043 Device Description: The Smisson-Ca…	Belmont Instrument Corp.	1998	—
*	K972284	Fluid Management System Summary page 5 …LGZ; FRN; FPA Legally Marketed Predicate Device: Belmont Fluid Management System (FMS2000) - 510(k) # K032778, K032674, K992672, K983975, K972284 Smiths Level 1® H-1200 Fast Flow Fluid Warmer System - 510(k) # BK020043 Device Description: The Smisson-Cartledge T…	Belmont Instrument Corp.	1997	1
Kept off the family tree	K020043	FDA’s K020043 is 4.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM Arthrex… The summary prints BK020043, a CBER number, which our reading took as K020043, FDA’s number for 4.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM… (Arthrex, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Smiths Level 1® H-1200 Fast Flow Fluid Warmer System”. Kept off the family tree. Summary page 5 …id Management System (FMS2000) - 510(k) # K032778, K032674, K992672, K983975, K972284 Smiths Level 1® H-1200 Fast Flow Fluid Warmer System - 510(k) # BK020043 Device Description: The Smisson-Cartledge TIS-1200 Thermal Infusion System is a portable tabletop or pole- mount dev…	Arthrex, Inc.	2002	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K202461	ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System	Smisson-Cartledge Biomedical, LLC	2022	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 18, 2021	Class I	Z-1259-2021	Component design/selection	Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Feb 18, 2021	Class I	Z-1260-2021	Component design/selection	Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Feb 18, 2021	Class I	Z-1258-2021	Component design/selection	Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
2 of the 6 ancestors have a recall of any class.
Of its descendants, K202461 (Smisson-Cartledge Biomedical, LLC, 2022) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LGZ devices

LGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LGZ

2in 2025

2007high 7 (2012) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LGZ

546in 2022

2007high 546 (2022) · low 77 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LGZ

1in 2016

2007high 8 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LGZ

376in 2025

2007high 1,548 (2022) · low 10 (2008)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?

Full range from slow feed to rapid, high flow infusion of.

* crystalloid, colloid, or blood product, including packed red blood cells, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K052055 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052055: Smisson-Cartledge Thermal Infusion System, Model Tis-1200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052055

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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