510(k) Report

510(k) · Cleared

Cleared

Citrisol Acid Concentrate

K130511510(k) TraditionalCleared Feb 10, 2014348-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

Diasol, Inc. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Cleared on Feb 10, 2014 as substantially equivalent to K854391 (Dana Laboratories, 1986) and 3 other predicates after a 348-day review. Its family tree reaches back 1 generation to 1986. 5 later devices descend from it.

Decided
Feb 10, 2014
Review
348 days
Class
Class II
Product code
KPO
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K854391 (1986). 4 ancestors in all. 5 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor2023: 1 descendant cleared2017: 1 descendant cleared2018: 2 descendants cleared2026: 1 descendant clearedK854391 · Hemodialysis Concentrate · Dana Laboratories · 19861990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 4 descendants2 generations forward: 1 descendant K854391 · Hemodialysis Concentrate · Dana Laboratories · 19860
  1. Root · 1 generation backK854391 Hemodialysis ConcentrateDana Laboratories · 1986
  2. This deviceK130511 Citrisol Acid ConcentrateDiasol, Inc. · 2014
  3. Descendant · cites it directly · 2 of its ownK171750 Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC · 2018 · Recalled
  4. Descendant · cites it directly · 1 of its ownK223431 Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp. · 2023 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK260799 Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026
  6. Descendant · cites it directly · 0 of its ownK180679 CitriCon Liquid and Powder (Acid Concentrate acidified with Citric…Global Scientific Technologies, LLC · 2018
  7. Descendant · cites it directly · 0 of its ownK171015 CitryteDi-Chem, Inc. · 2017

Most influential descendants

Showing 5 of 5 · See all
  • K171750Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC · 2018 · cites it directly2descendants
  • K223431Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp. · 2023 · cites it directly1descendant
  • K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026 · 2 generations on0descendants
  • K180679CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon…Global Scientific Technologies, LLC · 2018 · cites it directly0descendants
  • K171015CitryteDi-Chem, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K854391Hemodialysis ConcentrateDana Laboratories1986—
0 (this device)K130511Citrisol Acid ConcentrateDiasol, Inc.2014—
+1K171750Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC20182
+1K223431Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp.20231
+2K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated2026—
+1K180679CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid)…Global Scientific Technologies, LLC2018—
+1K171015CitryteDi-Chem, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201820
202310
202610
FIG. 1 — Lineage of K130511, 1986–2026Source: 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), 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. #1 K233159 pureFLOW 402, pureFLOW 400, pureFLOW 406…score 14.5 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K854391Hemodialysis Concentrate
Summary page 1
…emodialysis system and accessories CLASS I ACID CONCENTRATE FOR HEMODIALYSIS USE 21 CFR 876.5820 Hemadialysis system and accessories CLASS I Diasol Acid concentrate K854391 Dryasol Concentrate K993212 Citrapure K062399 Citrasate K000792 SAFETY AND EFFECHVENESS INFORMATION SUPPORTING THE SUBSTANTIAL…
Dana Laboratories1986—
*K993212Dryasol Acid Concentrate Mix
Summary page 1
…sories CLASS I ACID CONCENTRATE FOR HEMODIALYSIS USE 21 CFR 876.5820 Hemadialysis system and accessories CLASS I Diasol Acid concentrate K854391 Dryasol Concentrate K993212 Citrapure K062399 Citrasate K000792 SAFETY AND EFFECHVENESS INFORMATION SUPPORTING THE SUBSTANTIAL FOQUIVALENCE DETERMINATION…
Diasol, Inc.1999—
*K062399Rockwell Medicaltechnologies, Inc. Citrapure
Summary page 1
…CID CONCENTRATE FOR HEMODIALYSIS USE 21 CFR 876.5820 Hemadialysis system and accessories CLASS I Diasol Acid concentrate K854391 Dryasol Concentrate K993212 Citrapure K062399 Citrasate K000792 SAFETY AND EFFECHVENESS INFORMATION SUPPORTING THE SUBSTANTIAL FOQUIVALENCE DETERMINATION FEB 10 2014 ===…
Rockwell Medical Technologies, Inc.2006—
*K000792Citrasate Dialysate Acid Concentrate Liquid, Models CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX
Summary page 1
…HEMODIALYSIS USE 21 CFR 876.5820 Hemadialysis system and accessories CLASS I Diasol Acid concentrate K854391 Dryasol Concentrate K993212 Citrapure K062399 Citrasate K000792 SAFETY AND EFFECHVENESS INFORMATION SUPPORTING THE SUBSTANTIAL FOQUIVALENCE DETERMINATION FEB 10 2014 K130511…
Advanced Renal Technologies, Inc.2000—

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K171750Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC20182
K223431Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp.20231
K180679CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon…Global Scientific Technologies, LLC20180
K171015CitryteDi-Chem, Inc.20170

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, K171750 (Dimesol USA, LLC, 2018) has gone furthest, with 2 descendants of its own.

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. 2014, this device’s year, is highlighted.

FDA decisions per year · KPO

2in 2025

2007: 22008: 22009: 12011: 12012: 22013: 12014: 22015: 12016: 12017: 32018: 22020: 52021: 12022: 22023: 32024: 32025: 22026 (partial year): 2
2007high 5 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPO

112in 2024

2017: 192 days median2020: 270 days median2023: 263 days median2024: 112 days median
2007high 270 (2020) · low 112 (2024)2026

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

Recalls per year · KPO

6in 2025

2007: 52008: 22009: 12011: 22012: 102015: 32016: 12017: 12018: 112019: 12020: 312022: 22024: 12025: 62026 (partial year): 9
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

2007: 52008: 82009: 32010: 1072011: 2232012: 702013: 3,8972014: 15,9162015: 8,3402016: 2402017: 802018: 972019: 792020: 2442021: 632022: 252023: 592024: 2592025: 95
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—55
20082—28
20091—13
20100—0107
20111—2223
20122—1070
20131—03,897
20142—015,916
20151—38,340
20161—1240
20173192180
20182—1197
20190—179
2020527031244
20211—063
20222—225
20233263059
202431121259
20252—695
20262—9—

What is it indicated for?

CitriSol acid concentrate dry powder or liquid is indicated for use in the acute and chronic Hemodialysis. It is an accessory to be used with the appropriate Hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO standard water for hemodialysis and Sodium Bicarbonate Mix.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Diasol, Inc.

10 FDA decisions under this applicant name. See the company

  • K020231Diasol-AdditivesDiasol, Inc. · 2002
  • K020230Diasol-BicarbDiasol, Inc. · 2002
  • K011004Needlelok Hypodermic Needle ProtectionDiasol, Inc. · 2001
  • K010958Fistulok Fistula Needle ProtectionDiasol, Inc. · 2001
  • K011003Safesting and Safesting HubDiasol, Inc. · 2001

Recent decisions in KPO

The KPO category page

  • K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026
  • K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLC · 2026
  • K252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403…Fresenius Medical Care Renal Therapies Group, LLC · 2025
  • K243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407…Fresenius Medical Care Renal Therapies Group, LLC · 20252 recalls
  • K240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and Development · 2024

https://510kreport.com/device/K130511 · printed Nov 3, 2026

Cite this page

510(k) Report. “K130511: Citrisol Acid Concentrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K130511

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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