510(k) · Cleared
Recalled · 2012Dialysol-Acid Concentrate Liquid, Granusol-Acid Concentrate Powder, Renalsol-Acetate Concentrate Liquid & Powder, Biosol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solution Technologies · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on May 26, 1998 after a 67-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 6 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled once.
- Decided
- May 26, 1998
- Review
- 67 days
- Class
- Class II
- Product code
- KPO
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 3 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- This deviceK981043 Dialysol-Acid Concentrate Liquid, Granusol-Acid Concentrate Powder…Solution Technologies · 1998
- Descendant · cites it directly · 1 of its ownK192017 Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC · 2020 · Recalled
- Descendant · cites it directly · 1 of its ownK191474 NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry…Fresenius Medical Care Renal Therapies Group, LLC · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK253462 NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK212620 Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC · 2022 · Recalled
- Descendant · cites it directly · 0 of its ownK071387 Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrate, Model…Fresenius Medical Care North America · 2007 · Recalled (Class I)
Class I recalls in this family
- K071387 Fresenius Naturalyte Sodium Bicarbonate Liquid…cites it directly · 2007
Most influential descendants
Showing 5 of 5 · See all- K192017Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC · 2020 · cites it directly1descendant
- K191474NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate…Fresenius Medical Care Renal Therapies Group, LLC · 2020 · cites it directly1descendant
- K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLC · 2026 · 2 generations on0descendants
- K212620Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC · 2022 · 2 generations on0descendants
- K071387Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrate, Model 08-4000-LBFresenius Medical Care North America · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981043 | Dialysol-Acid Concentrate Liquid, Granusol-Acid Concentrate Powder… | Solution Technologies | 1998 | — |
| +1 | K192017 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | 6 |
| +1 | K191474 | NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate… | Fresenius Medical Care Renal Therapies Group, LLC | 2020 | 1 |
| +2 | K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | Fresenius Medical Care Renal Therapies Group, LLC | 2026 | — |
| +2 | K212620 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | 2022 | 2 |
| +1 | K071387 | Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrate, Model 08-4000-LB | Fresenius Medical Care North America | 2007 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 1 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2012 | Not classified | Z-1612-2012 | Process control | Sodium content does not meet product requirements |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K071387Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrate, Model 08-4000-LBFresenius Medical Care North America · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K192017 (Fresenius Medical Care Renal Therapies Group, LLC, 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KPO devicesKPO 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
2026 to Oct 25, outlined.
Median 510(k) review, days · KPO
112in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPO
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPO
95in 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?
THIS CONCENTRATE IS FORMULATED TO BE USED WITH A THREE STREAM HEMODIALYSIS MACHINE CALIBRATED FOR ACID AND BICARBONATE CONCENTRATES.
THIS CONCENTRATE IS FORMULATED TO BE USED WITH A TWO STREAM HEMODIALYSIS MACHINE CALIBRATED TO AN ACETATE CONCENTRATE DILUTION RATIO OF 1: [unclear in source].
THIS CONCENTRATE IS FORMULATED TO BE USED WITH A THREE STREAM HEMODIALYSIS MACHINE CALIBRATED FOR ACID AND BICARBONATE CONCENTRATES.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981043 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981043: Dialysol-Acid Concentrate Liquid, Granusol-Acid Concentrate Powder, Renalsol-Acetate Concentrate Liquid & Powder, Biosol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981043
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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