510(k) Report

510(k) · Cleared

Cleared

Rockwell Medicaltechnologies, Inc. Citrapure

K062399510(k) TraditionalCleared Nov 17, 200693-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

Rockwell Medical Technologies, Inc. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Cleared on Nov 17, 2006 after a 93-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.

Decided
Nov 17, 2006
Review
93 days
Class
Class II
Product code
KPO
Recalls
None
Predicates
0

6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2018: 2 descendants cleared2014: 1 descendant cleared2023: 1 descendant cleared2017: 1 descendant cleared2026: 1 descendant cleared20052010201520202025
  1. This deviceK062399 Rockwell Medicaltechnologies, Inc. CitrapureRockwell Medical Technologies, Inc. · 2006
  2. Descendant · cites it directly · 5 of its ownK130511 Citrisol Acid ConcentrateDiasol, Inc. · 2014
  3. Descendant · 2 generations on · 2 of its ownK171750 Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC · 2018 · Recalled
  4. Descendant · 2 generations on · 1 of its ownK223431 Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp. · 2023 · Recalled
  5. Descendant · 3 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

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2014: 12017: 12018: 22023: 12026: 1
2014high 2 (2018) · low 0 (2015)2026

Most influential descendants

Showing 5 of 6 · See all
  • K130511Citrisol Acid ConcentrateDiasol, Inc. · 2014 · 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
  • K180679CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon…Global Scientific Technologies, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K062399Rockwell Medicaltechnologies, Inc. CitrapureRockwell Medical Technologies, Inc.2006—
+1K130511Citrisol Acid ConcentrateDiasol, Inc.2014—
+2K171750Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC20182
+2K223431Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp.20231
+3K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated2026—
+1K180679CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid)…Global Scientific Technologies, LLC2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201710
201820
202310
202610
FIG. 1 — Lineage of K062399, 2006–2026Source: 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
Get a 510(k) Report

What was it cleared against? (2)

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
*—Rockwell Medical Technologies Dri-Sate® Acid Concentrate
Named without a submission number
—
*—Advanced Renal Technologies DRYalysate concentrates for hemodialysis
Named without a submission number
—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K130511Citrisol Acid ConcentrateDiasol, Inc.20145
K180679CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon…Global Scientific Technologies, LLC20180

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?

  • Of its descendants, K130511 (Diasol, Inc., 2014) has gone furthest, with 5 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.

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?

The Rockwell Medical Technologies CitraPure® Acid Concentrate powders/liquids for bicarbonate dialysate are indicated for use in acute and chronic hemodialysis and are to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.

Indications for use as stated in the FDA summary.

More from Rockwell Medical Technologies, Inc.

5 FDA decisions under this applicant name. See the company

  • K023985Acidified Component Concentrates for Bicarbonate Dialysis Containing DI-AcetateRockwell Medical Technologies, Inc. · 2003
  • K022521Bicarbonate Dialysate Concentrate Mixer, Model 50 Gallon & 100 GallonRockwell Medical Technologies, Inc. · 20032 recalls
  • K022500Dri-Sate Dry Acid Concentrate for Bicarbonate DialysateRockwell Medical Technologies, Inc. · 2002
  • K983618Dri-Sate Mixer for Preparation of Acidified Dialysate ConcentrateRockwell Medical Technologies, Inc. · 1999

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/K062399 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062399: Rockwell Medicaltechnologies, Inc. Citrapure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062399

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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