510(k) · Cleared

Cleared

Dryalysate Concentrate

K980659510(k) TraditionalCleared Jun 11, 1998111-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

Advanced Renal Technologies, Inc. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Cleared on Jun 11, 1998 as substantially equivalent to K911459 (Fresenius USA, Inc., 1991) and 3 other predicates after a 111-day review. Its family tree reaches back 1 generation to 1987. 7 later devices descend from it.

Decided: Jun 11, 1998
Review: 111 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. 7 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
This deviceK980659 Dryalysate ConcentrateAdvanced Renal Technologies, Inc. · 1998
Descendant · cites it directly · 5 of its ownK160847 Rockwell Medical CitraPure Acid ConcetrateRockwell Medical · 2016
Descendant · 2 generations on · 2 of its ownK171750 Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC · 2018 · Recalled
Descendant · 2 generations on · 1 of its ownK223431 Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp. · 2023 · Recalled
Descendant · 3 generations on · 0 of its ownK260799 Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026
Descendant · cites it directly · 0 of its ownK192209 Citrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC · 2020 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2016high 2 (2018) · low 0 (2019)2026

Most influential descendants

Showing 5 of 7 · See all

K160847Rockwell Medical CitraPure Acid ConcetrateRockwell Medical · 2016 · cites it directly5descendants
K171750Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC · 2018 · 2 generations on2descendants
K223431Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp. · 2023 · 2 generations on1descendant
K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026 · 3 generations on0descendants
K192209Citrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC · 2020 · cites it directly0descendants

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)	K980659	Dryalysate Concentrate	Advanced Renal Technologies, Inc.	1998	—
+1	K160847	Rockwell Medical CitraPure Acid Concetrate	Rockwell Medical	2016	—
+2	K171750	Citric Complete Dry Citric Acid (45X)	Dimesol USA, LLC	2018	2
+2	K223431	Citric Complete Liquid Citric Acid Concentrate	Nipro Renal Solutions USA, Corp.	2023	1
+3	K260799	Nipro Dry Acid Concentrate Mixer	Nipro Technical Solutions, Incoporated	2026	—
+1	K192209	Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate	Fresenius Medical Care Renal Therapies Group, LLC	2020	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1991	1	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2017	1	0
2018	2	0
2020	1	0
2023	1	0
2026	1	0

FIG. 1 — Lineage of K980659, 1987–2026Source: 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

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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
*	K911459	Granulyte Powder Dialysate Concentrate and Mixing Summary page 2 …ducts supplied by Fresenius USA sold as Granuflo™ Dry Acid Concentrate (originally granted FDA marketing approval as Granulyte™ Powder Dialysate Concentrate; 510 (k) #'s K911459 and K922005), Dial Medical’s DMF (Dial Medical of Florida, Inc.) Hemodialysis Concentrates; 510 (k) # K864265, and Granite Chemic…	Fresenius USA, Inc.	1991	2
*	K922005	Granulyte Dialysate Concentrate Summary page 2 …ed by Fresenius USA sold as Granuflo™ Dry Acid Concentrate (originally granted FDA marketing approval as Granulyte™ Powder Dialysate Concentrate; 510 (k) #'s K911459 and K922005), Dial Medical’s DMF (Dial Medical of Florida, Inc.) Hemodialysis Concentrates; 510 (k) # K864265, and Granite Chemical’s GC-1000…	Fresenius USA, Inc.	1994	—
*	K864265	Hemodialysis Bath Concentrate Solutions for Hemodi Summary page 2 …val as Granulyte™ Powder Dialysate Concentrate; 510 (k) #'s K911459 and K922005), Dial Medical’s DMF (Dial Medical of Florida, Inc.) Hemodialysis Concentrates; 510 (k) # K864265, and Granite Chemical’s GC-1000, GC-2000 and GC-3000 formulas; 510 (k) # K901471, all of which have been determined equivalent to…	Dial Medical of Florida, Inc.	1987	—
*	K901471	GC-1000 Through GC-3005 Acid Concentrate Summary page 2 …Dial Medical’s DMF (Dial Medical of Florida, Inc.) Hemodialysis Concentrates; 510 (k) # K864265, and Granite Chemical’s GC-1000, GC-2000 and GC-3000 formulas; 510 (k) # K901471, all of which have been determined equivalent to pre-enactment devices. Available dialysate concentration formulations supplied…	Granite Chemical Co., Inc.	1990	—

Also cleared against K911459: 2 other devices →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K160847	Rockwell Medical CitraPure Acid Concetrate	Rockwell Medical	2016	5
K192209	Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate	Fresenius Medical Care Renal Therapies Group, LLC	2020	0
K171015	Citryte	Di-Chem, Inc.	2017	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?

1 of the 4 ancestors has a recall of any class.
Of its descendants, K160847 (Rockwell Medical, 2016) has gone furthest, with 5 descendants of its own.
2 other devices also cite its predicate K911459.

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?

DRYalysate™ Concentrate is indicated for use for patients being treated by hemodialysis. The patient population that will use this device are those who suffer from loss of kidney function and who are prescribed acute or chronic hemodialysis. The indications for use of this product are exactly the same as those for currently marketed dialysate concentrates.

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/K980659 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980659: Dryalysate Concentrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980659

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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