510(k) · Cleared
ClearedGC-1000 Through GC-3005 Acid Concentrate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Granite Chemical Co., Inc. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Jul 27, 1990 after a 121-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Jul 27, 1990
- Review
- 121 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK901471 GC-1000 Through GC-3005 Acid ConcentrateGranite Chemical Co., Inc. · 1990
- Descendant · cites it directly · 7 of its ownK980659 Dryalysate ConcentrateAdvanced Renal Technologies, Inc. · 1998
- Descendant · 2 generations on · 5 of its ownK160847 Rockwell Medical CitraPure Acid ConcetrateRockwell Medical · 2016
- Descendant · 3 generations on · 2 of its ownK171750 Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC · 2018 · Recalled
- Descendant · cites it directly · 1 of its ownK223431 Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp. · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK260799 Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K980659Dryalysate ConcentrateAdvanced Renal Technologies, Inc. · 1998 · cites it directly7descendants
- K160847Rockwell Medical CitraPure Acid ConcetrateRockwell Medical · 2016 · 2 generations on5descendants
- K171750Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC · 2018 · 3 generations on2descendants
- K223431Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp. · 2023 · cites it directly1descendant
- K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K901471 | GC-1000 Through GC-3005 Acid Concentrate | Granite Chemical Co., Inc. | 1990 | — |
| +1 | K980659 | Dryalysate Concentrate | Advanced Renal Technologies, Inc. | 1998 | — |
| +2 | K160847 | Rockwell Medical CitraPure Acid Concetrate | Rockwell Medical | 2016 | — |
| +3 | K171750 | Citric Complete Dry Citric Acid (45X) | Dimesol USA, LLC | 2018 | 2 |
| +1 | K223431 | Citric Complete Liquid Citric Acid Concentrate | Nipro Renal Solutions USA, Corp. | 2023 | 1 |
| +2 | K260799 | Nipro Dry Acid Concentrate Mixer | Nipro Technical Solutions, Incoporated | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
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 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K980659 (Advanced Renal Technologies, Inc., 1998) has gone furthest, with 7 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.
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 | — |
https://510kreport.com/device/K901471 · printed Nov 6, 2026
Cite this page
510(k) Report. “K901471: GC-1000 Through GC-3005 Acid Concentrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K901471
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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