510(k) · Cleared
Recalled · Class II · 2012Fluid Management System
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 Nov 13, 1997 as substantially equivalent to K852645 (Haemonetics Corp., 1985) after a 147-day review. Its family tree reaches back 1 generation to 1985. 1 of the 11 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it. It has been recalled once.
- Decided
- Nov 13, 1997
- Review
- 147 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K852645 (1985). 9 later devices descend from it, 6 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK852645 Fluid Management SystemHaemonetics Corp. · 1985
- This deviceK972284 Fluid Management SystemBelmont Instrument Corp. · 1997
- Descendant · cites it directly · 5 of its ownK032674 Belmont Fluid Management System, Model FMS2000Belmont Instrument Corp. · 2003 · Recalled
- Descendant · cites it directly · 3 of its ownK992672 Belmont Fluid Management System (FMS2000)Belmont Instrument Corp. · 1999
- Descendant · cites it directly · 2 of its ownK141654 The Belmont Rapid InfuserBelmont Instrument Corporation · 2014
- Descendant · cites it directly · 2 of its ownK032778 Large Volume Fluid ReservoirBelmont Instrument Corp. · 2003
- Descendant · cites it directly · 2 of its ownK983975 Belmont Fluid Management System (FMS2000)Belmont Instrument Corp. · 1998
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K052055 Smisson-Cartledge Thermal Infusion System, Model…cites it directly · 2006
Most influential descendants
Showing 5 of 9 · See all- K032674Belmont Fluid Management System, Model FMS2000Belmont Instrument Corp. · 2003 · cites it directly5descendants
- K992672Belmont Fluid Management System (FMS2000)Belmont Instrument Corp. · 1999 · cites it directly3descendants
- K141654The Belmont Rapid InfuserBelmont Instrument Corporation · 2014 · cites it directly2descendants
- K032778Large Volume Fluid ReservoirBelmont Instrument Corp. · 2003 · cites it directly2descendants
- K983975Belmont Fluid Management System (FMS2000)Belmont Instrument Corp. · 1998 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852645 | Fluid Management System | Haemonetics Corp. | 1985 | — |
| 0 (this device) | K972284 | Fluid Management System | Belmont Instrument Corp. | 1997 | — |
| +1 | K032674 | Belmont Fluid Management System, Model FMS2000 | Belmont Instrument Corp. | 2003 | 1 |
| +1 | K992672 | Belmont Fluid Management System (FMS2000) | Belmont Instrument Corp. | 1999 | — |
| +1 | K141654 | The Belmont Rapid Infuser | Belmont Instrument Corporation | 2014 | — |
| +1 | K032778 | Large Volume Fluid Reservoir | Belmont Instrument Corp. | 2003 | — |
| +1 | K983975 | Belmont Fluid Management System (FMS2000) | Belmont Instrument Corp. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 1 |
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 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.
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 |
|---|---|---|---|
| * | K852645 | Fluid Management SystemSummary page 1…o the Haemonetics Corporation Rapid Infusion System, R.I.S.®, which has been in commercial distribution since 1987, and which was the subject of Premarket Notification #K852645 submitted in June, 1985. Attachment III Belmont Instrument Corporation 9. 10. 11. Brief Description: The Belm… | 1985 |
What descends from it? (9)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032674 | Belmont Fluid Management System, Model FMS2000 | 2003 | 5 |
| K992672 | Belmont Fluid Management System (FMS2000) | 1999 | 3 |
| K141654 | The Belmont Rapid Infuser | 2014 | 2 |
| K032778 | Large Volume Fluid Reservoir | 2003 | 2 |
| K983975 | Belmont Fluid Management System (FMS2000) | 1998 | 2 |
| K052055 | Smisson-Cartledge Thermal Infusion System, Model Tis-1200 Class I | 2006 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2012 | Class II | Z-0058-2013 | Device Design | Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Power Entry Module causing an electrical flash at the power entry area. |
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?
- Its one ancestor has no recall.
- Of its descendants, K032674 (Belmont Instrument Corp., 2003) has gone furthest, with 5 descendants of its own.
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/K972284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972284: Fluid Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972284
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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