510(k) · Cleared
ClearedBelmont Fluid Management System (FMS2000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Belmont Instrument Corp. · FRN Pump, Infusion
Cleared on Aug 24, 1999 as substantially equivalent to K972284 (Belmont Instrument Corp., 1997) after a 14-day review. Its family tree reaches back 2 generations to 1985. 1 of the 6 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Aug 24, 1999
- Review
- 14 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K852645 (1985). 3 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK852645 Fluid Management SystemHaemonetics Corp. · 1985
- 1 generation backK972284 Fluid Management SystemBelmont Instrument Corp. · 1997 · Recalled
- This deviceK992672 Belmont Fluid Management System (FMS2000)Belmont Instrument Corp. · 1999
- Descendant · cites it directly · 2 of its ownK032778 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 3 of 3 · See all- K032778Large Volume Fluid ReservoirBelmont Instrument Corp. · 2003 · cites it directly2descendants
- K052055Smisson-Cartledge Thermal Infusion System, Model Tis-1200Smisson-Cartledge Biomedical, LLC · 2006 · cites it directly1descendant
- K202461ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion SystemSmisson-Cartledge Biomedical, LLC · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852645 | Fluid Management System | Haemonetics Corp. | 1985 | — |
| −1 | K972284 | Fluid Management System | Belmont Instrument Corp. | 1997 | 1 |
| 0 (this device) | K992672 | Belmont Fluid Management System (FMS2000) | Belmont Instrument Corp. | 1999 | — |
| +1 | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 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 |
|---|---|---|---|
| * | K972284 | Fluid Management SystemSummary page 1…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. Brief Description of the Device (Unchanged by the Modification): The Belmont Fluid Management System (SZ… | 1997 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 2 companies; a new generation was cleared every 11.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K032778 (Belmont Instrument Corp., 2003) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K972284.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
A 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.
B. Infusion of warmed fluid to rewarm patients after surgery or for hypothermia.
C. Infusion of 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/K992672 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992672: Belmont Fluid Management System (FMS2000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992672
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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