510(k) · Cleared
ClearedLarge Volume Fluid Reservoir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Belmont Instrument Corp. · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Sep 22, 2003 as substantially equivalent to K972284 (Belmont Instrument Corp., 1997) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 1985. 1 of the 6 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Sep 22, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K852645 (1985). 2 later devices descend from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK852645 Fluid Management SystemHaemonetics Corp. · 1985
- 2 generations backK972284 Fluid Management SystemBelmont Instrument Corp. · 1997 · Recalled
- 1 generation backK992672 Belmont Fluid Management System (FMS2000)Belmont Instrument Corp. · 1999
- This deviceK032778 Large Volume Fluid ReservoirBelmont Instrument Corp. · 2003
- Descendant · cites it directly · 1 of its ownK052055 Smisson-Cartledge Thermal Infusion System, Model Tis-1200Smisson-Cartledge Biomedical, LLC · 2006 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK202461 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…cites it directly · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K852645 | Fluid Management System | Haemonetics Corp. | 1985 | — |
| −2 | K972284 | Fluid Management System | Belmont Instrument Corp. | 1997 | 1 |
| −1 | K992672 | Belmont Fluid Management System (FMS2000) | Belmont Instrument Corp. | 1999 | — |
| 0 (this device) | 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 |
| +2 | K202461 | ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion… | Smisson-Cartledge Biomedical, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 1 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K972284 | Fluid Management SystemSummary page 4…luid Management Disposable Set System is substantially equivalent to the Belmont Fluid Management Disposable Set System, which was the subject of Premarket Notification #K972284 submitted in June 1997 and the accessory kits received F.D.A 510(k) concurrence to market in August 1999, 510(k) #K992672. ===… | 1997 |
| * | K992672 | Belmont Fluid Management System (FMS2000)Summary page 4…ich was the subject of Premarket Notification #K972284 submitted in June 1997 and the accessory kits received F.D.A 510(k) concurrence to market in August 1999, 510(k) #K992672. Summary of Safety and Effectiveness Page 20of 3 Aug 22, 2003 10. 11. Brief Description of the SZ#S2000 Device… | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052055 | Smisson-Cartledge Thermal Infusion System, Model Tis-1200 Class I | 2006 | 1 |
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 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K052055 (Smisson-Cartledge Biomedical, LLC, 2006) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K972284.
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Infusion of crystalloid, colloid, or blood product, including packed red cells, as volume replacement for patients suffering from blood loss due to trauma or surgery.
Infusion of warmed fluid to rewarm patients after surgery or for hypothermia.
Infusion of warmed fluid for irrigation in urology purposes.
The reservoir is used for convenience in infusing large volumes of fluid (rather than having to change individual bags.) Tubing and fittings are added, same as the existing reservoir, to be used with our current disposable set.
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/K032778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032778: Large Volume Fluid Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032778
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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