510(k) · Cleared
ClearedThe Belmont Rapid Infuser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Belmont Instrument Corporation · FRN Pump, Infusion
Cleared on Jul 18, 2014 as substantially equivalent to K972284 (Belmont Instrument Corp., 1997) and 2 other predicates after a 28-day review. Its family tree reaches back 3 generations to 1985. 2 later devices descend from it.
- Decided
- Jul 18, 2014
- Review
- 28 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K852645 (1985). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK852645 Fluid Management SystemHaemonetics Corp. · 1985
- 2 generations backK972284 Fluid Management SystemBelmont Instrument Corp. · 1997 · Recalled
- 1 generation backK032674 Belmont Fluid Management System, Model FMS2000Belmont Instrument Corp. · 2003 · Recalled
- This deviceK141654 The Belmont Rapid InfuserBelmont Instrument Corporation · 2014
- Descendant · cites it directly · 0 of its ownK251733 Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life) · 2025
- Descendant · cites it directly · 0 of its ownK242735 Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min)…Belmont Medical Technologies · 2024 · Recalled
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 | K032674 | Belmont Fluid Management System, Model FMS2000 | Belmont Instrument Corp. | 2003 | 1 |
| 0 (this device) | K141654 | The Belmont Rapid Infuser | Belmont Instrument Corporation | 2014 | — |
| +1 | K251733 | Fluido® AirGuard System | The Surgical Company International BV (As Tsc Life) | 2025 | — |
| +1 | K242735 | Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid… | Belmont Medical Technologies | 2024 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 FRN? 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? (3)
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 2…the Belmont' Rapid Infuser which was originally cleared to market under 510(k) K972284 on November 13, 1997, and to the Belmonto Rapid Infuser 750 mI/mmn flow rate was… | 1997 |
| * | K032674 | Belmont Fluid Management System, Model FMS2000Summary page 1…Which Substantial Equivalence is entry originally under 51 0(k) K(972284, Claimed: 1 modification cleared under 51 0(k) K032674, and 2"d modification cleared under 510(k) K091855. Device Descriptio… | 2003 |
| * | K091855 | The Belmont Fluid Management System/ the Belmont Rapid Infuser, Model FMS2000Summary page 1…laimed: 1 modification cleared under 51 0(k) K032674, and 2"d modification cleared under 510(k) K091855. Device Description:' The Belmontt Rapid Infuser, R12, (same as the… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 29 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K251733 (The Surgical Company International BV (As Tsc Life), 2025) has gone furthest, with 0 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. 2014, this device’s year, is highlighted.
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 as stated in the FDA summary.
https://510kreport.com/device/K141654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141654: The Belmont Rapid Infuser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141654
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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