510(k) · Cleared
ClearedIsopure Dry Acid Dissolution System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isopure, Corp. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Jan 22, 2020 as substantially equivalent to K131611 (Fresenius Medical Care North America, 2013) after a 272-day review. Its family tree reaches back 1 generation to 2013. 1 later device descends from it.
- Decided
- Jan 22, 2020
- Review
- 272 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K131611 (2013). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK131611 Fresenius Dry Acid Dissolution UnitsFresenius Medical Care North America · 2013 · Recalled
- This deviceK191093 Isopure Dry Acid Dissolution SystemIsopure, Corp. · 2020
- Descendant · cites it directly · 0 of its ownK260799 Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026
Most influential descendants
Showing 1 of 1 · See all- K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K131611 | Fresenius Dry Acid Dissolution Units | Fresenius Medical Care North America | 2013 | 2 |
| 0 (this device) | K191093 | Isopure Dry Acid Dissolution System | Isopure, Corp. | 2020 | — |
| +1 | K260799 | Nipro Dry Acid Concentrate Mixer | Nipro Technical Solutions, Incoporated | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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 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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131611 | Fresenius Dry Acid Dissolution UnitsSummary page 4…is System and Accessories Regulation Number: 21 CFR 876.5820 Predicate Device for Substantial Equivalence: Fresenius Medical Care Dry Acid Dissolution Unit, K131611 Device Description: The Isopure Dry Acid Dissolution System consists mainly of a Mixing Tank,… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260799 | Nipro Dry Acid Concentrate Mixer | 2026 | 0 |
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?
- Its one ancestor has a recall.
- Of its descendants, K260799 (Nipro Technical Solutions, Incoporated, 2026) has gone furthest, with 0 descendants 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. 2020, 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 Isopure Corp Dry Acid Dissolution System is designed to mix dry acid concentrates with purified water to produce an acid concentrate solution for hemodialysis for use in 3- Stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191093: Isopure Dry Acid Dissolution System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191093
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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