510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Fresenius Hemoflow F3, F4, F5, F7

K874872510(k) TraditionalCleared Feb 19, 198884-day reviewClass II21 CFR 876.5820Recalls 1

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

Seratronics, Inc. · FJI Dialyzer, Capillary, Hollow Fiber

Cleared on Feb 19, 1988 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.

Decided
Feb 19, 1988
Review
84 days
Class
Class II
Product code
FJI
Recalls
1
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2025: 2 descendants cleared1990200020102020
  1. This deviceK874872 Fresenius Hemoflow F3, F4, F5, F7Seratronics, Inc. · 1988
  2. Descendant · cites it directly · 2 of its ownK190459 Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLC · 2019
  3. Descendant · 2 generations on · 1 of its ownK242053 FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC · 2025
  4. Descendant · 3 generations on · 0 of its ownK253518 FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC · 2025

Most influential descendants

Showing 3 of 3 · See all
  • K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLC · 2019 · cites it directly2descendants
  • K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 2 generations on1descendant
  • K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K874872Fresenius Hemoflow F3, F4, F5, F7Seratronics, Inc.1988—
+1K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLC2019—
+2K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC2025—
+3K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202520
FIG. 1 — Lineage of K874872, 1988–2025Source: 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.

Planning a device in FJI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (3)

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

NumberDeviceApplicantDecidedDescendants
K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLC20192

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 26, 2016Class IIZ-1324-2016Process controlDialyzer header leak due to possible improper torque

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K190459 (Fresenius Medical Care Renal Therapies Group, LLC, 2019) has gone furthest, with 2 descendants of its own.

How does its category compare?

All FJI devices

FJI Dialyzer, Capillary, Hollow Fiber: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FJI

1in 2019

2013: 12019: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FJI

Too few FJI 510(k)s in any year since 2007 to give a median.

Recalls per year · FJI

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FJI

145in 2025

2007: 172008: 112009: 32010: 322011: 472012: 2112013: 5532014: 6332015: 5612016: 5622017: 1822018: 112019: 202020: 162021: 122022: 22023: 512024: 1522025: 145
2007high 633 (2014) · low 2 (2022)2025

MAUDE reports naming product code FJI, 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
20070—017
20080—011
20090—03
20100—032
20110—047
20120—0211
20131—0553
20140—0633
20150—0561
20160—0562
20170—0182
20180—011
20191—020
20200—016
20210—012
20220—02
20230—051
20240—0152
20250—1145
20260—0—

More from Seratronics, Inc.

21 FDA decisions under this applicant name. See the company

  • K955299DPS 4 Dialyzer Preparation SystemSeratronics, Inc. · 1996
  • K931336DRS 4 Dialyzer Reprocessing SystemSeratronics, Inc. · 1996
  • K944539DRS 4 ND Dialyzer Reprocessing SystemSeratronics, Inc. · 1995
  • K923529DMS Data Management System/DRS-4 Dialyzer ReprocesSeratronics, Inc. · 1994
  • K914580DRS-4 Dialyzer Reprocessing SystemSeratronics, Inc. · 1992

Recent decisions in FJI

The FJI category page

  • K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLC · 2019
  • K122952Nipro Pureflux-L HemodialyzerNipro Medical Corporation · 2013
  • K043342Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L, 17L, 21L, 140H, 170H…Gambro Renal Products · 2005
  • K010366Disposable Storage CapMolded Products, Inc. · 2001
  • K011148Ultraconcentrator SystemInterpore Cross Intl. · 2001

https://510kreport.com/device/K874872 · printed Nov 6, 2026

Cite this page

510(k) Report. “K874872: Fresenius Hemoflow F3, F4, F5, F7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K874872

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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