510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

Dialysate Concentrate for Hemodialysis-Liquid/Powd

K843963510(k) TraditionalCleared Jan 7, 198588-day reviewClass II21 CFR 876.5820Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Renal Systems, Inc. · FKQ System, Dialysate Delivery, Central Multiple Patient

Cleared on Jan 7, 1985 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled once.

Decided
Jan 7, 1985
Review
88 days
Class
Class II
Product code
FKQ
Recalls
1
Predicates
0

5 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2020: 1 descendant cleared2018: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK843963 Dialysate Concentrate for Hemodialysis-Liquid/PowdRenal Systems, Inc. · 1985
  2. Descendant · cites it directly · 4 of its ownK131202 Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R)…Dialysis Medical Solutions, LLC · 2014 · Recalled
  3. Descendant · 2 generations on · 2 of its ownK171750 Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC · 2018 · Recalled
  4. Descendant · 3 generations on · 1 of its ownK223431 Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp. · 2023 · Recalled
  5. Descendant · 4 generations on · 0 of its ownK260799 Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026
  6. Descendant · 2 generations on · 0 of its ownK193155 Nipro Dry Complete Dry Acid Concentrate for HemodialysisNipro Renal Solutions USA, Corp. · 2020

Most influential descendants

Showing 5 of 5 · See all
  • K131202Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder (45X)…Dialysis Medical Solutions, LLC · 2014 · cites it directly4descendants
  • K171750Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC · 2018 · 2 generations on2descendants
  • K223431Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp. · 2023 · 3 generations on1descendant
  • K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026 · 4 generations on0descendants
  • K193155Nipro Dry Complete Dry Acid Concentrate for HemodialysisNipro Renal Solutions USA, Corp. · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K843963Dialysate Concentrate for Hemodialysis-Liquid/PowdRenal Systems, Inc.1985—
+1K131202Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder…Dialysis Medical Solutions, LLC20141
+2K171750Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC20182
+3K223431Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp.20231
+4K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated2026—
+2K193155Nipro Dry Complete Dry Acid Concentrate for HemodialysisNipro Renal Solutions USA, Corp.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201810
202010
202310
202610
FIG. 1 — Lineage of K843963, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FKQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131202Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder (45X)…Dialysis Medical Solutions, LLC20144

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 20, 2021Class IIZ-1859-2021Process controlThe lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K131202 (Dialysis Medical Solutions, LLC, 2014) has gone furthest, with 4 descendants of its own.

How does its category compare?

All FKQ devices

FKQ System, Dialysate Delivery, Central Multiple Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FKQ

FDA has decided no FKQ device since 2007.

Median 510(k) review, days · FKQ

Too few FKQ 510(k)s in any year since 2007 to give a median.

Recalls per year · FKQ

No recall names FKQ since 2007.

Adverse event reports per year · FKQ

6in 2024

2010: 12017: 12019: 12021: 22023: 32024: 6
2007high 6 (2024) · low 0 (2007)2025

MAUDE reports naming product code FKQ, 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
20070—00
20080—00
20090—00
20100—01
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—01
20200—00
20210—02
20220—00
20230—03
20240—06
20250—00
20260—0—

More from Renal Systems, Inc.

35 FDA decisions under this applicant name. See the company

  • K970648Primus Hollow Fiber Dialyzer (Models 1000,1000S,1350,1350S,2000,2000S)Renal Systems, Inc. · 1998
  • K861730Actril for Kidney Machine DisinfectantRenal Systems, Inc. · 1987
  • K854011Renalfo Hemofilter CavhdRenal Systems, Inc. · 1985
  • K844790Renaflo HemoconcentratorRenal Systems, Inc. · 1985
  • K844108Renal Systems Peritoneal Access SystemRenal Systems, Inc. · 1985

Recent decisions in FKQ

The FKQ category page

  • K052764Diacap Ultra Dialysis Fluid FilterB. Braun Medizintechnologie GmbH · 20061 recall
  • K893612Two Tank Dissolution ModuleNational Medical Care, Medical Products Div., Inc. · 1989
  • K874084Multiple Artificial Kidney Systems (Maks) #IdmNational Medical Care, Medical Products Div., Inc. · 1988
  • K873421Kawasumi a.V. Fistula SetKawasumi Laboratories Co., Ltd. · 1987
  • K870889Acid Fuchsin SolutionsD.R.G. Scientific Industries · 1987

https://510kreport.com/device/K843963 · printed Nov 5, 2026

Cite this page

510(k) Report. “K843963: Dialysate Concentrate for Hemodialysis-Liquid/Powd.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K843963

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026