510(k) · Cleared
ClearedCitryte
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Di-Chem, Inc. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Oct 13, 2017 as substantially equivalent to K160847 (Rockwell Medical, 2016) and 2 other predicates after a 192-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Oct 13, 2017
- Review
- 192 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K864265 (1987). 11 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 deviceK171015 CitryteDi-Chem, Inc. · 2017
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) | K171015 | Citryte | Di-Chem, Inc. | 2017 | — |
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 |
| 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? (3)
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 |
|---|---|---|---|
| * | K160847 | Rockwell Medical CitraPure Acid ConcetrateSummary page 4…prior submissions for this device PREDICATE DEVICES: Primary Predicate Devices: Rockwell Medical Technologies CitraPure (K160847) Diasol Inc. Citrisol (K130511) Reference Predicate Devices:… | 2016 |
| * | K130511 | Citrisol Acid ConcentrateSummary page 4…Primary Predicate Devices: Rockwell Medical Technologies CitraPure (K160847) Diasol Inc. Citrisol (K130511) Reference Predicate Devices: Advanced Renal Technologies Inc.… | 2014 |
| * | K980659 | Dryalysate ConcentrateSummary page 4…Diasol Inc. Citrisol (K130511) Reference Predicate Devices: Advanced Renal Technologies Inc. (K980659) Di-Chem Inc. (K012328) DEVICE DESCRIPTION: The Di-Chem, Inc. proposed Citryte hemodialysis ac… | 1998 |
| † | K012328 | Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate Powder | 2002 |
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 30 years and passes through 4 companies; a new generation was cleared every 11.2 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 3 other devices also cite its predicate K160847.
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. 2017, 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 Di-Chem, Inc. Citryte Acid Concentrate for bicarbonate dialysis is indicated for use in the treatment of acute and chronic hemodialysis. It is to be used with the appropriate hemodialysis machine and sodium bicarbonate concentrate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171015: Citryte.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171015
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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