510(k) · Cleared

Cleared

Prismaflex System 8.10

K171671510(k) TraditionalCleared Feb 23, 2018262-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

Baxter Healthcare Corporation · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Feb 23, 2018 as substantially equivalent to K131516 (Gambro Renal Products, Inc., 2014) after a 262-day review. Its family tree reaches back 1 generation to 2014. 1 of the 6 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.

Decided: Feb 23, 2018
Review: 262 days
Class: Class II
Product code: KDI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K131516 (2014). 4 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK131516 Prismaflex System 7.10Gambro Renal Products, Inc. · 2014 · Recalled
This deviceK171671 Prismaflex System 8.10Baxter Healthcare Corporation · 2018
Descendant · cites it directly · 2 of its ownK190910 PrisMax System Version 2Baxter Healthcare Corp · 2019 · Recalled
Descendant · 2 generations on · 0 of its ownK212216 Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation · 2022 · Recalled
Descendant · 2 generations on · 0 of its ownK193482 PrisMax System Version 3Baxter Healthcare Corporation · 2020 · Recalled
Descendant · cites it directly · 0 of its ownK192756 Aquadex FlexFlow System 2.0Chf Solutions, Inc. · 2020 · Recalled (Class I)

Class I recalls in this family

K192756 Aquadex FlexFlow System 2.0cites it directly · 2020

Most influential descendants

Showing 4 of 4 · See all

K190910PrisMax System Version 2Baxter Healthcare Corp · 2019 · cites it directly2descendants
K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation · 2022 · 2 generations on0descendants
K193482PrisMax System Version 3Baxter Healthcare Corporation · 2020 · 2 generations on0descendants
K192756Aquadex FlexFlow System 2.0Chf Solutions, Inc. · 2020 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K131516	Prismaflex System 7.10	Gambro Renal Products, Inc.	2014	4
0 (this device)	K171671	Prismaflex System 8.10	Baxter Healthcare Corporation	2018	—
+1	K190910	PrisMax System Version 2	Baxter Healthcare Corp	2019	5
+2	K212216	Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set	Baxter Healthcare Corporation	2022	3
+2	K193482	PrisMax System Version 3	Baxter Healthcare Corporation	2020	2
+1	K192756	Aquadex FlexFlow System 2.0	Chf Solutions, Inc.	2020	Class I

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2020	2	1
2022	1	0

FIG. 1 — Lineage of K171671, 2014–2022Source: 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? (1)

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
*	K131516	Prismaflex System 7.10 Summary page 5 …4. PREDICATE DEVICE: Device Predicate 510(k) Clearance Date Prismaflex System 7.10 K131516 January 3, 2014 5. DESCRIPTION OF THE DEVICE: The Prismaflex control unit…	Gambro Renal Products, Inc.	2014	4

Also cleared against K131516: 1 other device →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K190910	PrisMax System Version 2	Baxter Healthcare Corp	2019	2
K192756	Aquadex FlexFlow System 2.0 Class I	Chf Solutions, Inc.	2020	0

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.

K192756Aquadex FlexFlow System 2.0Chf Solutions, Inc. · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K190910 (Baxter Healthcare Corp, 2019) has gone furthest, with 2 descendants of its own.
1 other device also cites its predicate K131516.

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. 2018, this device’s year, is highlighted.

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 control unit is intended for:

• Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.

• Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K171671 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171671: Prismaflex System 8.10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171671

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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