510(k) Report

510(k) · Cleared

Cleared

Fresenius F Series Hemoconcentrators F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS

K974584510(k) TraditionalCleared May 14, 1998157-day reviewClass II21 CFR 876.5860

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

Fresenius USA, Inc. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on May 14, 1998 as substantially equivalent to K971180 (C.R. Bard, Inc., 1997) and 4 other predicates after a 157-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.

Decided
May 14, 1998
Review
157 days
Class
Class II
Product code
KDI
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K902837 (1990). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1990: 1 other ancestor1999: 1 descendant clearedK902837 · Amicon Diafilter 30 Hemoconcentrator · Amicon, Inc. · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant K902837 · Amicon Diafilter 30 Hemoconcentrator · Amicon, Inc. · 19900
  1. Root · 1 generation backK902837 Amicon Diafilter 30 HemoconcentratorAmicon, Inc. · 1990
  2. This deviceK974584 Fresenius F Series Hemoconcentrators…Fresenius USA, Inc. · 1998
  3. Descendant · cites it directly · 0 of its ownK992275 Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified…Fresenius USA, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all
  • K992275Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low Vol…Fresenius USA, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K902837Amicon Diafilter 30 HemoconcentratorAmicon, Inc.1990—
0 (this device)K974584Fresenius F Series Hemoconcentrators…Fresenius USA, Inc.1998—
+1K992275Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low…Fresenius USA, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199410
199510
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K974584, 1990–1999Source: 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), 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 KDI? 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 KDI device

  1. #1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 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? (8)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K971180Bard NO-Rinse Hemoconcentrator and Accessory Kit
Summary page 1
…oncentrator Classification Name: High Permeability Hemodialysis System Legally Marketed Device to which substantial equivalence is claimed: Bard HC40 Hemoconcentrator (K971180) Amicon Diafilter 30 (K902837) Minntech Hemocor HPH 1000 (K923139) Baxter Bentley Quick Prime HQ 7000 (K903641) Research Medica…
C.R. Bard, Inc.1997—
*K902837Amicon Diafilter 30 Hemoconcentrator
Summary page 1
…me: High Permeability Hemodialysis System Legally Marketed Device to which substantial equivalence is claimed: Bard HC40 Hemoconcentrator (K971180) Amicon Diafilter 30 (K902837) Minntech Hemocor HPH 1000 (K923139) Baxter Bentley Quick Prime HQ 7000 (K903641) Research Medical Biofilter 140 {K951344 and K…
Amicon, Inc.1990—
*K923139Hemocor HP Hemoconcentrator Series
Summary page 1
…stem Legally Marketed Device to which substantial equivalence is claimed: Bard HC40 Hemoconcentrator (K971180) Amicon Diafilter 30 (K902837) Minntech Hemocor HPH 1000 (K923139) Baxter Bentley Quick Prime HQ 7000 (K903641) Research Medical Biofilter 140 {K951344 and K370739) Intended Use: The Fresenius…
Minntech Corp.19941
*K903641Quick Prime Hemoconcen. NO. HQ-7000 and CBP-7000Q
Summary page 1
…tial equivalence is claimed: Bard HC40 Hemoconcentrator (K971180) Amicon Diafilter 30 (K902837) Minntech Hemocor HPH 1000 (K923139) Baxter Bentley Quick Prime HQ 7000 (K903641) Research Medical Biofilter 140 {K951344 and K370739) Intended Use: The Fresenius F Series Hemoconcentrators are indicated to r…
Bentley Laboratories, Inc.1990—
*K951344Rmi Hemoconcentrator
Summary page 1
…moconcentrator (K971180) Amicon Diafilter 30 (K902837) Minntech Hemocor HPH 1000 (K923139) Baxter Bentley Quick Prime HQ 7000 (K903641) Research Medical Biofilter 140 {K951344 and K370739) Intended Use: The Fresenius F Series Hemoconcentrators are indicated to relieve or mitigate overhydration in patie…
Research Medical, Inc.1995—
Kept off the family treeK370739Research Medical Biofilter 140
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 1
…or (K971180) Amicon Diafilter 30 (K902837) Minntech Hemocor HPH 1000 (K923139) Baxter Bentley Quick Prime HQ 7000 (K903641) Research Medical Biofilter 140 {K951344 and K370739) Intended Use: The Fresenius F Series Hemoconcentrators are indicated to relieve or mitigate overhydration in patients undergoi…
*—Fresenius F40
Named without a submission number
—
*—Fresenius F60
Named without a submission number
—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K992275Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low Vol…Fresenius USA, Inc.19990

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?

  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K992275 (Fresenius USA, Inc., 1999) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KDI devices

KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KDI

9in 2025

2007: 112008: 62009: 42010: 92011: 52012: 62013: 112014: 82015: 52016: 52017: 82018: 22019: 42020: 92021: 22022: 72023: 72024: 72025: 92026 (partial year): 6
2007high 11 (2007) · low 2 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDI

199in 2025

2007: 91 days median2008: 148 days median2009: 236 days median2010: 186 days median2011: 85 days median2012: 153 days median2013: 247 days median2014: 164 days median2015: 69 days median2016: 230 days median2017: 188 days median2019: 263 days median2020: 266 days median2022: 259 days median2023: 157 days median2024: 235 days median2025: 199 days median2026 (partial year): 154 days median
2007high 266 (2020) · low 69 (2015)2026

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

Recalls per year · KDI

2in 2025

2007: 42009: 32010: 12011: 42012: 12013: 22014: 32015: 52016: 42017: 12018: 12019: 62021: 22022: 172023: 8, 8 Class I2024: 4, 2 Class I2025: 22026 (partial year): 2
2007high 17 (2022) · low 0 (2008)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · KDI

2,786in 2025

2007: 9162008: 1,0422009: 5222010: 8232011: 2,2702012: 1,7652013: 2,3602014: 6,1542015: 4,1822016: 7662017: 9632018: 1,7162019: 1,5872020: 1,6332021: 1,9442022: 2,1802023: 2,6922024: 2,4412025: 2,786
2007high 6,154 (2014) · low 522 (2009)2025

MAUDE reports naming product code KDI, 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
200711914916
2008614801,042
200942363522
201091861823
201158542,270
2012615311,765
20131124722,360
2014816436,154
201556954,182
201652304766
201781881963
20182—11,716
2019426361,587
2020926601,633
20212—21,944
20227259172,180
202371578 (8)2,692
202472354 (2)2,441
2025919922,786
202661542—

What is it indicated for?

The Fresenius F Series Hemoconcentrators are indicated to relieve

or mitigate overhydration in patients undergoing cardiopulmonary

procedures and to increase the concentration of cells and proteins

in the blood.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Fresenius USA, Inc.

38 FDA decisions under this applicant name. See the company

  • K992275Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low Vol Hemoconcentrator W/Tubing…Fresenius USA, Inc. · 1999
  • K970700Fresenius Polysulfone Hemodialyzers, Both Low and High FluxFresenius USA, Inc. · 1998
  • K973378C.a.T.S Continuous Autotransfusion System Model 900500 1, AT1 Autotransfusion Set Model 900 510 1, PSQ Set…Fresenius USA, Inc. · 1997
  • K9614652008H on Line Clearance MonitorFresenius USA, Inc. · 1997
  • K961706P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell SeparatorFresenius USA, Inc. · 19961 recall

Recent decisions in KDI

The KDI category page

  • K261203multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2026
  • K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC · 2026
  • K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC · 2026
  • K260533Elisio™-HNipro Medical Corporation · 2026
  • K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC · 2026

https://510kreport.com/device/K974584 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974584: Fresenius F Series Hemoconcentrators F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974584

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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