510(k) · Cleared
Recalled · Class II · 2015Fresenius Dry Acid Dissolution Units
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care North America · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Aug 29, 2013 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 29, 2013
- Review
- 87 days
- Class
- Class II
- Product code
- KPO
- Recalls
- 2
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK131611 Fresenius Dry Acid Dissolution UnitsFresenius Medical Care North America · 2013
- Descendant · cites it directly · 1 of its ownK191093 Isopure Dry Acid Dissolution SystemIsopure, Corp. · 2020
- Descendant · 2 generations on · 0 of its ownK260799 Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K131611 | Fresenius Dry Acid Dissolution Units | Fresenius Medical Care North America | 2013 | — |
| +1 | K191093 | Isopure Dry Acid Dissolution System | Isopure, Corp. | 2020 | — |
| +2 | K260799 | Nipro Dry Acid Concentrate Mixer | Nipro Technical Solutions, Incoporated | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
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 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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191093 | Isopure Dry Acid Dissolution System | 2020 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 23, 2015 | Class II | Z-0295-2016 | Device Design | Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire. |
| Oct 23, 2015 | Class II | Z-0296-2016 | Device Design | Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K191093 (Isopure, Corp., 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. 2013, this device’s year, is highlighted.
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?
The Fresenius Medical Care Dry Acid Dissolution Unit mixes Fresenius Medical Care distributed dry acid concentrate products with hemodialysis quality water. The resulting liquid acid concentrates are intended for use in three-stream hemodialysis machines calibrated for acid and bicarbonate concentrates.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K131611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131611: Fresenius Dry Acid Dissolution Units.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131611
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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