510(k) Report

510(k) · Cleared

Cleared

Fluid Management System

K852645510(k) TraditionalCleared Dec 9, 1985171-day reviewClass II21 CFR 880.5725

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Haemonetics Corp. · FRN Pump, Infusion

Cleared on Dec 9, 1985 after a 171-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 11 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.

Decided
Dec 9, 1985
Review
171 days
Class
Class II
Product code
FRN
Recalls
None
Predicates
0

10 later devices descend from it, 1 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 1 descendant cleared1998: 1 descendant cleared2006: 1 descendant cleared, 1 with a Class I recall11999: 1 descendant cleared2014: 1 descendant cleared2003: 2 descendants cleared2022: 1 descendant cleared2025: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK852645 Fluid Management SystemHaemonetics Corp. · 1985
  2. Descendant · cites it directly · 9 of its ownK972284 Fluid Management SystemBelmont Instrument Corp. · 1997 · Recalled
  3. Descendant · 2 generations on · 5 of its ownK032674 Belmont Fluid Management System, Model FMS2000Belmont Instrument Corp. · 2003 · Recalled
  4. Descendant · 2 generations on · 3 of its ownK992672 Belmont Fluid Management System (FMS2000)Belmont Instrument Corp. · 1999
  5. Descendant · 2 generations on · 2 of its ownK141654 The Belmont Rapid InfuserBelmont Instrument Corporation · 2014
  6. Descendant · 2 generations on · 2 of its ownK032778 Large Volume Fluid ReservoirBelmont Instrument Corp. · 2003

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

1997: 11998: 11999: 12003: 22006: 12014: 12022: 12024: 12025: 1
1997high 2 (2003) · low 0 (2000)2026

Class I recalls in this family

  • K052055 Smisson-Cartledge Thermal Infusion System, Model…2 generations on · 2006

Most influential descendants

Showing 5 of 10 · See all
  • K972284Fluid Management SystemBelmont Instrument Corp. · 1997 · cites it directly9descendants
  • K032674Belmont Fluid Management System, Model FMS2000Belmont Instrument Corp. · 2003 · 2 generations on5descendants
  • K992672Belmont Fluid Management System (FMS2000)Belmont Instrument Corp. · 1999 · 2 generations on3descendants
  • K141654The Belmont Rapid InfuserBelmont Instrument Corporation · 2014 · 2 generations on2descendants
  • K032778Large Volume Fluid ReservoirBelmont Instrument Corp. · 2003 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K852645Fluid Management SystemHaemonetics Corp.1985—
+1K972284Fluid Management SystemBelmont Instrument Corp.19971
+2K032674Belmont Fluid Management System, Model FMS2000Belmont Instrument Corp.20031
+2K992672Belmont Fluid Management System (FMS2000)Belmont Instrument Corp.1999—
+2K141654The Belmont Rapid InfuserBelmont Instrument Corporation2014—
+2K032778Large Volume Fluid ReservoirBelmont Instrument Corp.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199910
200320
200611
201410
202210
202410
202510
FIG. 1 — Lineage of K852645, 1985–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972284Fluid Management SystemBelmont Instrument Corp.19979

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 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 13 Class I recalls

What does this lineage say?

  • Of its descendants, K972284 (Belmont Instrument Corp., 1997) has gone furthest, with 9 descendants of its own.

How does its category compare?

All FRN devices

FRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRN

8in 2025

2007: 122008: 82009: 92010: 32011: 32012: 42013: 62014: 62015: 32016: 32017: 32018: 32019: 22020: 12021: 22022: 62023: 72024: 52025: 82026 (partial year): 2
2007high 12 (2007) · low 1 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRN

172in 2025

2007: 102 days median2008: 89 days median2009: 66 days median2010: 93 days median2011: 103 days median2012: 217 days median2013: 312 days median2014: 172 days median2015: 232 days median2016: 301 days median2017: 305 days median2018: 267 days median2022: 268 days median2023: 265 days median2024: 103 days median2025: 172 days median
2007high 312 (2013) · low 66 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRN

7in 2025

2007: 152008: 242009: 1022010: 372011: 692012: 42, 2 Class I2013: 22, 3 Class I2014: 4, 3 Class I2015: 52016: 7, 1 Class I2017: 132018: 12019: 18, 1 Class I2020: 16, 5 Class I2021: 3, 2 Class I2022: 22023: 16, 10 Class I2024: 9, 4 Class I2025: 7, 4 Class I2026 (partial year): 11, 2 Class I
2007high 102 (2009) · low 1 (2018)2026

Class I (37 since 2007) Class II/III not classified

Adverse event reports per year · FRN

52,792in 2025

2007: 1,0862008: 8,2612009: 1,9522010: 6,1332011: 41,3672012: 15,4822013: 40,0822014: 94,1802015: 26,7422016: 16,5602017: 12,0602018: 16,5912019: 15,8502020: 94,1862021: 199,3422022: 888,0202023: 165,8382024: 57,7302025: 52,792
2007high 888,020 (2022) · low 1,086 (2007)2025

MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200712102151,086
2008889248,261
20099661021,952
2010393376,133
201131036941,367
2012421742 (2)15,482
2013631222 (3)40,082
201461724 (3)94,180
20153232526,742
201633017 (1)16,560
201733051312,060
20183267116,591
20192—18 (1)15,850
20201—16 (5)94,186
20212—3 (2)199,342
202262682888,020
2023726516 (10)165,838
202451039 (4)57,730
202581727 (4)52,792
20262—11 (2)—

More from Haemonetics Corp.

28 FDA decisions under this applicant name. See the company

  • K122262Orthopat Advance Perioperative Autotransfusion SystemHaemonetics Corp. · 20121 recall
  • K120586Cell Saver EliteHaemonetics Corp. · 2012
  • K101907Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corp. · 20106 recalls
  • K062801Smartsuction Solo DeviceHaemonetics Corp. · 2006
  • K061103Haemonetics 40U RBC Filter BagHaemonetics Corp. · 2006

Recent decisions in FRN

The FRN category page

  • K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp · 2026
  • K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc. · 2026
  • K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation · 20251 recall
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  • K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025

https://510kreport.com/device/K852645 · printed Nov 4, 2026

Cite this page

510(k) Report. “K852645: Fluid Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K852645

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026