510(k) · Cleared
Recalled · Class II · 2025Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Belmont Medical Technologies · FRN Pump, Infusion
Cleared on Dec 23, 2024 as substantially equivalent to K141654 (Belmont Instrument Corporation, 2014) after a 103-day review. Its family tree reaches back 4 generations to 1985. It has been recalled 2 times.
- Decided
- Dec 23, 2024
- Review
- 103 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K852645 (1985). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK852645 Fluid Management SystemHaemonetics Corp. · 1985
- 3 generations backK972284 Fluid Management SystemBelmont Instrument Corp. · 1997 · Recalled
- 2 generations backK032674 Belmont Fluid Management System, Model FMS2000Belmont Instrument Corp. · 2003 · Recalled
- 1 generation backK141654 The Belmont Rapid InfuserBelmont Instrument Corporation · 2014
- This deviceK242735 Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min)…Belmont Medical Technologies · 2024
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 | K032674 | Belmont Fluid Management System, Model FMS2000 | Belmont Instrument Corp. | 2003 | 1 |
| −1 | K141654 | The Belmont Rapid Infuser | Belmont Instrument Corporation | 2014 | — |
| 0 (this device) | K242735 | Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid… | Belmont Medical Technologies | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (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 |
|---|---|---|---|
| * | K141654 | The Belmont Rapid InfuserSummary page 5…, Class II Classification Product Code: FRN Subsequent Product Code: LGZ Predicate Device: K141654: The Belmont Rapid Infuser This predicate has not been subject to a design-related recall. Devic… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 31, 2025 | Class II | Z-1678-2025 | Process design | Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser. |
| Jan 2, 2025 | Class II | Z-1099-2025 | Process control | Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 39 years and passes through 4 companies; a new generation was cleared every 10.8 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K141654.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The Belmont Rapid Infuser RI-2 is designed to be used in general operation in hospital or alternative care environments to
provide warmed blood and fluids to any patients ≥ 10 kg requiring warmed infusion from 2.5 mL/min to 1000 mL/min.
- 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.
- Infusion of warmed fluid to rewarm patients after surgery or for hypothermia.
- Infusion of warmed fluid for irrigation in urology procedures.
The 3.0L reservoir is an optional accessory for use in adults only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242735 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242735: Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242735
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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