510(k) · Cleared

Recalled · Class II · 2026

Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets

K041005510(k) AbbreviatedCleared Oct 7, 2004171-day reviewClass II21 CFR 876.5860Recalls 7

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

Gambro Renal Products · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Oct 7, 2004 as substantially equivalent to K021615 (Baxter Healthcare Corp, 2002) and 3 other predicates after a 171-day review. Its family tree reaches back 5 generations to 1991. 1 of the 30 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled 7 times.

Decided: Oct 7, 2004
Review: 171 days
Class: Class II
Product code: KDI
Recalls: 7
Predicates: 4

Its longest line of descent runs back 5 generations to K910215 (1991). 25 ancestors in all, the oldest K850569 (1985). 4 later devices descend from it, 3 citing it directly. 1 of the 30 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 5 generations backK910215 Drake Willock System 1000 Dialysate Delivery SystCd Medical, Inc. · 1991 · Recalled
4 generations backK954987 Altratouch 1000 Hemodialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1996 · Recalled
3 generations backK970446 Drake Willock System & Altra Touch 1000 Dialysis Delivery SystemAlthin Medical AB an Affiliate of Baxter Intl · 1997 · Recalled
2 generations backK993064 Prisma CFM (Continuous Fluid Management System)Gambro Renal Care Products · 1999 · Recalled
1 generation backK021615 Baxter Accura System, Model 5M5660Baxter Healthcare Corp · 2002 · Recalled
This deviceK041005 Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products · 2004
Descendant · cites it directly · 1 of its ownK080519 Prismaflex M150 SetGambro Renal Products, Inc. · 2008 · Recalled
Descendant · cites it directly · 1 of its ownK042938 Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products · 2005 · Recalled
Descendant · 2 generations on · 0 of its ownK220281 multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2022
Descendant · cites it directly · 0 of its ownK212216 Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation · 2022 · Recalled

Class I recalls in this family

K963440 Dialog Dialysis Machinedirect predicate · 1998

Most influential descendants

Showing 4 of 4 · See all

K080519Prismaflex M150 SetGambro Renal Products, Inc. · 2008 · cites it directly1descendant
K042938Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products · 2005 · cites it directly1descendant
K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2022 · 2 generations on0descendants
K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K910215	Drake Willock System 1000 Dialysate Delivery Syst	Cd Medical, Inc.	1991	5
−4	K954987	Altratouch 1000 Hemodialysis Delivery System	Althin Medical AB an Affiliate of Baxter Intl	1996	1
−3	K970446	Drake Willock System & Altra Touch 1000 Dialysis Delivery System	Althin Medical AB an Affiliate of Baxter Intl	1997	5
−2	K993064	Prisma CFM (Continuous Fluid Management System)	Gambro Renal Care Products	1999	1
−1	K021615	Baxter Accura System, Model 5M5660	Baxter Healthcare Corp	2002	3
0 (this device)	K041005	Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets	Gambro Renal Products	2004	—
+1	K080519	Prismaflex M150 Set	Gambro Renal Products, Inc.	2008	3
+1	K042938	Gambro Prismaflex HF1000 and HF1400 Sets	Gambro Renal Products	2005	7
+2	K220281	multiFiltratePRO System	Fresenius Medical Care Renal Therapies Group, LLC	2022	—
+1	K212216	Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set	Baxter Healthcare Corporation	2022	3

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	2	0
1987	1	0
1988	1	0
1991	2	0
1993	1	0
1994	1	0
1995	1	0
1996	1	0
1997	3	0
1998	4	1
1999	1	0
2002	1	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2008	1	0
2022	2	0

FIG. 1 — Lineage of K041005, 1991–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 KDI device

#1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K021615	Baxter Accura System, Model 5M5660 Summary page 4 …terology - Urology (GU) CLASSIFICATION: Class II per 21 CFR 876.5860 PREDICATE DEVICES: Baxter Accura System K021615 B.Braun Diapact CRRT K963440 Gambro…	Baxter Healthcare Corp	2002	3
*	K963440	Dialog Dialysis Machine Summary page 4 …6.5860 PREDICATE DEVICES: Baxter Accura System K021615 B.Braun Diapact CRRT K963440 Gambro Prisma System K010805 Gambro…	B. Braun Medical AG	1998	Class I
*	K010805	Prisma System Summary page 4 …K021615 B.Braun Diapact CRRT K963440 Gambro Prisma System K010805 Gambro Prisma M60/M100 Sets K032431 DEVICE DESCRIPTION: The Prismaflex Syste…	Gambro Renal Products	2002	1
*	K032431	Prisma M60/M100 Sets Summary page 4 …K963440 Gambro Prisma System K010805 Gambro Prisma M60/M100 Sets K032431 DEVICE DESCRIPTION: The Prismaflex System is an acute renal failure treatment device for removal of waste products, restorat…	Gambro, Inc.	2003	6

Also cleared against K021615: 2 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K080519	Prismaflex M150 Set	Gambro Renal Products, Inc.	2008	1
K042938	Gambro Prismaflex HF1000 and HF1400 Sets	Gambro Renal Products	2005	1
K212216	Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set	Baxter Healthcare Corporation	2022	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 6, 2026	Class II	Z-1227-2026	Component design/selection	There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Sep 14, 2022	Class II	Z-0081-2023	Error in labeling	Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.
Jul 22, 2021	Class II	Z-2378-2021	Vendor change control	Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter. Data was manipulated to appear to be conforming
Jul 18, 2014	Class II	Z-2202-2014	Device Design	Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Jul 18, 2014	Class II	Z-2201-2014	Device Design	Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Jan 4, 2007	Not classified	Z-0695-2007	Device Design	Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines)
May 16, 2006	Not classified	Z-0032-2007	Software design	A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.

The 5 latest of 7 recalls; the web page lists all.

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.

K963440Dialog Dialysis MachineB. Braun Medical AG · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 16 Class I recalls

What does this lineage say?

The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
11 of the 25 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K080519 (Gambro Renal Products, Inc., 2008) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K021615.

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

2007high 11 (2007) · low 2 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDI

199in 2025

2007high 266 (2020) · low 69 (2015)2026

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

Recalls per year · KDI

2in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	11	91	4	916
2008	6	148	0	1,042
2009	4	236	3	522
2010	9	186	1	823
2011	5	85	4	2,270
2012	6	153	1	1,765
2013	11	247	2	2,360
2014	8	164	3	6,154
2015	5	69	5	4,182
2016	5	230	4	766
2017	8	188	1	963
2018	2	—	1	1,716
2019	4	263	6	1,587
2020	9	266	0	1,633
2021	2	—	2	1,944
2022	7	259	17	2,180
2023	7	157	8 (8)	2,692
2024	7	235	4 (2)	2,441
2025	9	199	2	2,786
2026	6	154	2	—

What is it indicated for?

The Prismaflex is indicated for the following use:

continuous solute and/or fluid removal in patients with acute renal failure or fluid overload

All treatments administered by the Prismaflex must be prescribed by a physician.

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/K041005 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041005: Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041005

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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