510(k) · Cleared

Cleared

Prismasate

K013448510(k) TraditionalCleared Jan 15, 200290-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 Renal Products · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Cleared on Jan 15, 2002 as substantially equivalent to K910270 (Baxter Healthcare Corp, 1991) and 3 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1987. 18 later devices descend from it.

Decided: Jan 15, 2002
Review: 90 days
Class: Class II
Product code: KPO
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K864265 (1987). 4 ancestors in all. 18 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
This deviceK013448 PrismasateGambro Renal Products · 2002
Descendant · cites it directly · 12 of its ownK022913 Nxstage Premixed DialysateNxstage Medical, Inc. · 2002
Descendant · 2 generations on · 10 of its ownK033386 Nxstage Pureflow SolutionNxstage Medical, Inc. · 2003
Descendant · 3 generations on · 8 of its ownK042045 Nxstage Pureflow-B SolutionNxstage Medical, Inc. · 2004 · Recalled
Descendant · cites it directly · 7 of its ownK041683 B. Braun Bicarbonate DialysateB.Braun Medical, Inc. · 2004
Descendant · cites it directly · 6 of its ownK072908 Prismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products · 2008 · Recalled

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2002high 4 (2004) · low 0 (2006)2026

Most influential descendants

Showing 5 of 18 · See all

K022913Nxstage Premixed DialysateNxstage Medical, Inc. · 2002 · cites it directly12descendants
K033386Nxstage Pureflow SolutionNxstage Medical, Inc. · 2003 · 2 generations on10descendants
K042045Nxstage Pureflow-B SolutionNxstage Medical, Inc. · 2004 · 3 generations on8descendants
K041683B. Braun Bicarbonate DialysateB.Braun Medical, Inc. · 2004 · cites it directly7descendants
K072908Prismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products · 2008 · cites it directly6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K864265	Hemodialysis Bath Concentrate Solutions for Hemodi	Dial Medical of Florida, Inc.	1987	—
0 (this device)	K013448	Prismasate	Gambro Renal Products	2002	—
+1	K022913	Nxstage Premixed Dialysate	Nxstage Medical, Inc.	2002	—
+2	K033386	Nxstage Pureflow Solution	Nxstage Medical, Inc.	2003	—
+3	K042045	Nxstage Pureflow-B Solution	Nxstage Medical, Inc.	2004	1
+1	K041683	B. Braun Bicarbonate Dialysate	B.Braun Medical, Inc.	2004	—
+1	K072908	Prismasate Dialysis Solutions for Continuous Renal Replacement Therapy	Gambro Renal Products	2008	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
2000	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	4	0
2005	2	0
2008	1	0
2012	1	0
2015	1	0
2017	1	0
2021	1	0
2023	1	0
2024	2	0
2025	2	0

FIG. 1 — Lineage of K013448, 1987–2025Source: 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.

Planning a device in KPO? 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 KPO device

#1 K233159 pureFLOW 402, pureFLOW 400, pureFLOW 406…score 14.5 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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
*	K910270	Premixed Dialysate for Hemodiafiltration Summary page 2 …Concentrate for Hemodialysis (Liquid or Powder) per 21 CFR 876.5820. The Product/Classification Code is KPO. Predicate Devices: Premixed Dialysate for Hemodiafiltration K910270 cleared 04/18/1991 Baxter Healthcare Corp. Normocarb Sterile Bicarbonate Renal Dialysis Concentrate K001059 cleared 06/30/2000…	Baxter Healthcare Corp	1991	—
*	K001059	Normocarb Sterile Bicarbonate Renal Dialysis Summary page 2 …Predicate Devices: Premixed Dialysate for Hemodiafiltration K910270 cleared 04/18/1991 Baxter Healthcare Corp. Normocarb Sterile Bicarbonate Renal Dialysis Concentrate K001059 cleared 06/30/2000 Dialysis Solutions, Inc. / Novex Pharma Hemodialysis Bath Concentrate Solutions for Hemodialysis K864265 clea…	Novex Pharma	2000	—
*	K864265	Hemodialysis Bath Concentrate Solutions for Hemodi Summary page 2 …rile Bicarbonate Renal Dialysis Concentrate K001059 cleared 06/30/2000 Dialysis Solutions, Inc. / Novex Pharma Hemodialysis Bath Concentrate Solutions for Hemodialysis K864265 cleared 03/17/1987 Dial Medical of Florida, Inc. Dry AC Acid Concentrate Mix for Bicarbonate Hemodialysis KO011368 cleared 08/02…	Dial Medical of Florida, Inc.	1987	—
*	K011368	Dry AC Acid Concentrate Mix for Bicarbonate Hemodialysis Summary page 3 …cial kidney equipment \| \ioonesium 0.5 - 1.5 mEg/L product for Bicarbonate \| using purified, AAMI Bicarbonate® 32 - 36 mEq/L Hemodialysis standard water. Lactate O mEg/L K011368 Cleared Acetate 3 -4 mEq/L *final dialysate concentration when mixed with sodium chioride/sodium bicarbonate buffer Comparing t…	Gambro Renal Products	2001	—

Also cleared against K910270: 4 other devices →

What descends from it? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K022913	Nxstage Premixed Dialysate	Nxstage Medical, Inc.	2002	12
K041683	B. Braun Bicarbonate Dialysate	B.Braun Medical, Inc.	2004	7
K072908	Prismasate Dialysis Solutions for Continuous Renal Replacement Therapy	Gambro Renal Products	2008	6
K120333	Prismasate Dialysis Solutions for Continuius Renal Replacement Therapy	Gambro Renal Products	2012	5
K041428	Accusol Dialysis Solution	Baxter Healthcare Corp	2004	2
K034066	B.Braun Premixed Dialysate	B.Braun Medical, Inc.	2004	0

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?

None of the 4 ancestors has a recall.
Of its descendants, K022913 (Nxstage Medical, Inc., 2002) has gone furthest, with 12 descendants of its own.
4 other devices also cite its predicate K910270.

How does its category compare?

All KPO devices

KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPO

2in 2025

2007high 5 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPO

112in 2024

2007high 270 (2020) · low 112 (2024)2026

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

Recalls per year · KPO

6in 2025

2007high 31 (2020) · low 0 (2010)2026

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

Adverse event reports per year · KPO

95in 2025

2007high 15,916 (2014) · low 3 (2009)2025

MAUDE reports naming product code KPO, 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	2	—	5	5
2008	2	—	2	8
2009	1	—	1	3
2010	0	—	0	107
2011	1	—	2	223
2012	2	—	10	70
2013	1	—	0	3,897
2014	2	—	0	15,916
2015	1	—	3	8,340
2016	1	—	1	240
2017	3	192	1	80
2018	2	—	11	97
2019	0	—	1	79
2020	5	270	31	244
2021	1	—	0	63
2022	2	—	2	25
2023	3	263	0	59
2024	3	112	1	259
2025	2	—	6	95
2026	2	—	9	—

What is it indicated for?

Gambro PrismaSate™ solutions are indicated for use as a dialysate in

Continuous Renal Replacement Therapy.

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/K013448 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013448: Prismasate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013448

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026