510(k) Report

510(k) · Cleared

Cleared

Gambro Alwall GFS Plus 11, 16 & 20 Hollow Fiber

K902481510(k) TraditionalCleared Jul 27, 199052-day reviewClass II21 CFR 876.5820

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

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

Cleared on Jul 27, 1990 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 23 later devices descend from it.

Decided
Jul 27, 1990
Review
52 days
Class
Class II
Product code
FJI
Recalls
None
Predicates
0

23 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1996: 2 descendants cleared1999: 1 descendant cleared2003: 1 descendant cleared2004: 1 descendant cleared2006: 1 descendant cleared2005: 2 descendants cleared2020: 2 descendants cleared2022: 1 descendant cleared2023: 2 descendants cleared2016: 1 descendant cleared2013: 1 descendant cleared2007: 1 descendant cleared2026: 3 descendants cleared2025: 3 descendants cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK902481 Gambro Alwall GFS Plus 11, 16 & 20 Hollow FiberGambro, Inc. · 1990
  2. Descendant · cites it directly · 19 of its ownK030592 Gambro Polyflux, Model 140H, 170H, 210HGambro Renal Care Products · 2003
  3. Descendant · 2 generations on · 10 of its ownK040255 Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc. · 2004
  4. Descendant · 2 generations on · 9 of its ownK043342 Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple…Gambro Renal Products · 2005
  5. Descendant · 3 generations on · 6 of its ownK220721 FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600…Fresenius Medical Care Renal Therapies Group, LLC · 2023
  6. Descendant · 4 generations on · 2 of its ownK243874 FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100…Fresenius Medical Care Renal Therapies Group, LLC · 2025

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

1996: 21999: 12003: 12004: 12005: 22006: 12007: 12013: 12016: 12020: 22022: 12023: 22024: 12025: 32026: 3
1996high 3 (2025) · low 0 (1997)2026

Most influential descendants

Showing 5 of 23 · See all
  • K030592Gambro Polyflux, Model 140H, 170H, 210HGambro Renal Care Products · 2003 · cites it directly19descendants
  • K040255Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc. · 2004 · 2 generations on10descendants
  • K043342Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…Gambro Renal Products · 2005 · 2 generations on9descendants
  • K220721FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX…Fresenius Medical Care Renal Therapies Group, LLC · 2023 · 3 generations on6descendants
  • K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120…Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K902481Gambro Alwall GFS Plus 11, 16 & 20 Hollow FiberGambro, Inc.1990—
+1K030592Gambro Polyflux, Model 140H, 170H, 210HGambro Renal Care Products2003—
+2K040255Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc.2004—
+2K043342Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use…Gambro Renal Products2005—
+3K220721FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL…Fresenius Medical Care Renal Therapies Group, LLC2023—
+4K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX…Fresenius Medical Care Renal Therapies Group, LLC2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199910
200310
200410
200520
200610
200710
201310
201610
202020
202210
202320
202410
202530
202630
FIG. 1 — Lineage of K902481, 1990–2026Source: 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? (23)

See all 23

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K030592Gambro Polyflux, Model 140H, 170H, 210HGambro Renal Care Products200319
K990159Dynamic Hollow Fiber Dialyzer DH-Series, Model AH 90111Dynamic Technology Corp.19990
K962427Cobe Centrysystem 700 HG HemodialyzerGambro Healthcare19960
K960474Cobe Centrysystem 600 HG HemodialyzersCobe Renal Care, Inc.19960

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?

  • Of its descendants, K030592 (Gambro Renal Care Products, 2003) has gone furthest, with 19 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 Gambro, Inc.

86 FDA decisions under this applicant name. See the company

  • K083158Exalis, Software Version 1.15Gambro, Inc. · 2009
  • K070643Phoenix Hemodialysis Delivery System, Version 3.35Gambro, Inc. · 2007
  • K032431Prisma M60/M100 SetsGambro, Inc. · 20036 recalls
  • K896758Gambro Bicarbonate Monitor BCM 10-3Gambro, Inc. · 1990
  • K896757Gambro AK-10 Dialysis System for High FlowsGambro, Inc. · 1990

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/K902481 · printed Nov 6, 2026

Cite this page

510(k) Report. “K902481: Gambro Alwall GFS Plus 11, 16 & 20 Hollow Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902481

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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