510(k) · Cleared
ClearedCitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Scientific Technologies, LLC · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Dec 7, 2018 as substantially equivalent to K982378 (Solution Technologies, 1998) and 4 other predicates after a 267-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Dec 7, 2018
- Review
- 267 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K864265 (1987). 12 ancestors in all, the oldest K854391 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK864265 Hemodialysis Bath Concentrate Solutions for HemodiDial Medical of Florida, Inc. · 1987
- 2 generations backK980659 Dryalysate ConcentrateAdvanced Renal Technologies, Inc. · 1998
- 1 generation backK160847 Rockwell Medical CitraPure Acid ConcetrateRockwell Medical · 2016
- This deviceK180679 CitriCon Liquid and Powder (Acid Concentrate acidified with Citric…Global Scientific Technologies, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864265 | Hemodialysis Bath Concentrate Solutions for Hemodi | Dial Medical of Florida, Inc. | 1987 | — |
| −2 | K980659 | Dryalysate Concentrate | Advanced Renal Technologies, Inc. | 1998 | — |
| −1 | K160847 | Rockwell Medical CitraPure Acid Concetrate | Rockwell Medical | 2016 | — |
| 0 (this device) | K180679 | CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid)… | Global Scientific Technologies, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 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? (5)
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 |
|---|---|---|---|
| * | K982378 | Hemsol-Acid Concentrate Liquid Hemogran Acid Concentrate Powder, Nephrosol-Acetate…Summary page 8…Name: Class II, Hemodialysis System and Accessories Product Code: KPO: Gastroenterology/Urology 3. Predicate Device Names: 3.1. Solution Technologies – K982378 (PRIMARY PREDICATE) 3.1.1. Device Names: Hemosol, Hemogran, Nephrosol, Nephrogran, Bicarbosol and Bicarbogran… | 1998 |
| * | K160847 | Rockwell Medical CitraPure Acid ConcetrateSummary page 8…3.1.1. Device Names: Hemosol, Hemogran, Nephrosol, Nephrogran, Bicarbosol and Bicarbogran Dialysate Concentrate 3.2. Rockwell Medical Technologies, Inc – K160847 & K062399 (SECONDARY PREDICATE) 3.2.1. Device Name: CitraPure Acid Concentrate 3.3. Advanced Renal Technologie… | 2016 |
| * | K062399 | Rockwell Medicaltechnologies, Inc. CitrapureSummary page 8…ice Names: Hemosol, Hemogran, Nephrosol, Nephrogran, Bicarbosol and Bicarbogran Dialysate Concentrate 3.2. Rockwell Medical Technologies, Inc – K160847 & K062399 (SECONDARY PREDICATE) 3.2.1. Device Name: CitraPure Acid Concentrate 3.3. Advanced Renal Technologies, Inc – K… | 2006 |
| * | K000792 | Citrasate Dialysate Acid Concentrate Liquid, Models CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XXSummary page 8…cal Technologies, Inc – K160847 & K062399 (SECONDARY PREDICATE) 3.2.1. Device Name: CitraPure Acid Concentrate 3.3. Advanced Renal Technologies, Inc – K000792 (SECONDARY PREDICATE) 3.3.1. Device Name: Citrasate Acid Concentrate 3.4. Diasol, Inc. – K130511 (SECONDARY PREDICATE)… | 2000 |
| * | K130511 | Citrisol Acid ConcentrateSummary page 8…Acid Concentrate 3.3. Advanced Renal Technologies, Inc – K000792 (SECONDARY PREDICATE) 3.3.1. Device Name: Citrasate Acid Concentrate 3.4. Diasol, Inc. – K130511 (SECONDARY PREDICATE) 3.4.1. Device Name: Citrisol Acid Concentrate 3.5. Di-Chem, Inc. – K171015 (REFERENCE DEVICE)… | 2014 |
| † | K171015 | Citryte | 2017 |
| † | K012328 | Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate Powder | 2002 |
| † | K070177 | Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000 Series | 2007 |
| † | K071387 | Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrate, Model 08-4000-LB | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 11.2 years on median.
- 1 of the 12 ancestors has a recall of any class.
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. 2018, 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?
AcetiCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate. CitriCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic…
Read the full statement (196 words)
AcetiCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate.
CitriCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate.
BicarboCon bicarbonate concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with acid concentrate.
RenaCon acetate concentrate liquids or powders for acetate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 2 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis.
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/K180679 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180679: CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180679
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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