510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder (45X), Medicalyte (R) Bicarbonate Powder (35X

K131202510(k) TraditionalCleared Apr 3, 2014339-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

Dialysis Medical Solutions, LLC · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Cleared on Apr 3, 2014 as substantially equivalent to K954527 (Rockwell Medical Supply, 1996) and 2 other predicates after a 339-day review. Its family tree reaches back 1 generation to 1985. 4 later devices descend from it. It has been recalled once.

Decided
Apr 3, 2014
Review
339 days
Class
Class II
Product code
KPO
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K843963 (1985). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1996: 1 other ancestor2020: 1 descendant cleared2018: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant clearedK843963 · Dialysate Concentrate for Hemodialysis-Liquid/Powd · Renal Systems, Inc. · 1985 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K843963 · Dialysate Concentrate for Hemodialysis-Liquid/Powd · Renal Systems, Inc. · 1985 · recalled0
  1. Root · 1 generation backK843963 Dialysate Concentrate for Hemodialysis-Liquid/PowdRenal Systems, Inc. · 1985 · Recalled
  2. This deviceK131202 Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R)…Dialysis Medical Solutions, LLC · 2014
  3. Descendant · cites it directly · 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 ownK193155 Nipro Dry Complete Dry Acid Concentrate for HemodialysisNipro Renal Solutions USA, Corp. · 2020

Most influential descendants

Showing 4 of 4 · 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 · 2 generations on1descendant
  • K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026 · 3 generations on0descendants
  • K193155Nipro Dry Complete Dry Acid Concentrate for HemodialysisNipro Renal Solutions USA, Corp. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K843963Dialysate Concentrate for Hemodialysis-Liquid/PowdRenal Systems, Inc.19851
0 (this device)K131202Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder…Dialysis Medical Solutions, LLC2014—
+1K171750Citric 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—
+1K193155Nipro Dry Complete Dry Acid Concentrate for HemodialysisNipro Renal Solutions USA, Corp.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202010
202310
202610
FIG. 1 — Lineage of K131202, 1985–2026Source: 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? (3)

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
*K954527Rockwell Medical Supply LLC Hemodialysis Concentrate Solutions & Powders
Summary page 2
…5 10(K) SUMMARY UNDER 21 CFR 807.92 C. Legally Marketed Predicate Device Rockwell Medical Supply RenalPure® Powder Bicarbonate for Hemodialysis (K954527) Medivator Inc. Renasol®@ and Centrisol® Bicarbonate Concentrate Powder (K843963) Di-Chem, Inc. Hemo-Lyte Dry S…
Rockwell Medical Supply19963
*K843963Dialysate Concentrate for Hemodialysis-Liquid/Powd
Summary page 2
…Rockwell Medical Supply RenalPure® Powder Bicarbonate for Hemodialysis (K954527) Medivator Inc. Renasol®@ and Centrisol® Bicarbonate Concentrate Powder (K843963) Di-Chem, Inc. Hemo-Lyte Dry Sodium Bicarbonate-Chloride Concentrate and Dry Sodium Bicarbonate Concentrate (KO…
Renal Systems, Inc.19851
*K012328Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate Powder
Summary page 6
…ate Concentrate Powder (K843963) predicate devices, and the Di-Chem, Inc. Hemo-Lyte Dry Sodium Bicarbonate-Chloride Concentrate and Dry Sodium Bicarbonate Concentrate (KO012328) predicate devices, and are therefore expected to be as safe, as effective, and perform as well as the predicate devices. 510O(…
Di-Chem, Inc.2002—

Also cleared against K954527: 1 other device →

What descends from it? (4)

2 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
K193155Nipro Dry Complete Dry Acid Concentrate for HemodialysisNipro Renal Solutions USA, Corp.20200

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 5, 2026Class IIZ-3134-2026Process controlHemodialysis concentrates contain high endotoxin levels

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K171750 (Dimesol USA, LLC, 2018) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K954527.

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?

For DB-203; DB-204; DB-205: This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate or equivalent in a 36.83x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis. For DB-206; DB-207; DB-208: This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate or equivalent in a 45x three-stream artificial kidney (hemodialysis) machine…

Read the full statement (114 words)

For DB-203; DB-204; DB-205:

This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate or equivalent in a 36.83x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis.

For DB-206; DB-207; DB-208:

This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate or equivalent in a 45x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis.

For DB-209; DB-210; DB-211:

This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate or equivalent in a 35x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis.

Indications for use as stated in the FDA summary.

Also cleared against K954527

1 other device cites the same predicate.

  • K090002Acid Concentrate 45X (2.0K, 3.1CA), Model 5M8001A, Acid Concentrate 45X (2.0K, 2.5CA), Model 5M8002ABaxter Healthcare Corp · 2009

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/K131202 · printed Nov 4, 2026

Cite this page

510(k) Report. “K131202: Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder (45X), Medicalyte (R) Bicarbonate Powder (35X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K131202

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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