510(k) · Cleared
ClearedNipro Dry Complete Dry Acid Concentrate for Hemodialysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Renal Solutions USA, Corp. · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Cleared on Nov 25, 2020 as substantially equivalent to K901471 (Granite Chemical Co., Inc., 1990) and 2 other predicates after a 377-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Nov 25, 2020
- Review
- 377 days
- Class
- Class II
- Product code
- KPO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K843963 (1985). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK843963 Dialysate Concentrate for Hemodialysis-Liquid/PowdRenal Systems, Inc. · 1985 · Recalled
- 1 generation backK131202 Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R)…Dialysis Medical Solutions, LLC · 2014 · Recalled
- This deviceK193155 Nipro Dry Complete Dry Acid Concentrate for HemodialysisNipro Renal Solutions USA, Corp. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K843963 | Dialysate Concentrate for Hemodialysis-Liquid/Powd | Renal Systems, Inc. | 1985 | 1 |
| −1 | K131202 | Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder… | Dialysis Medical Solutions, LLC | 2014 | 1 |
| 0 (this device) | K193155 | Nipro Dry Complete Dry Acid Concentrate for Hemodialysis | Nipro Renal Solutions USA, Corp. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K901471 | GC-1000 Through GC-3005 Acid ConcentrateSummary page 4…ode: KPO: Gastroenterology/Urology C. Legally Marketed Predicate Devices Nipro Renal Solutions Corporation USA MedicaPure™ Liquid Acid Concentrate (K901471) Diasol, Inc. Dryasol Acid Concentrate Mix (K993212) Nipro Renal Solutions Corporation USA MedicaLyte™ Bicarbonate… | 1990 |
| * | K993212 | Dryasol Acid Concentrate MixSummary page 4…ed Predicate Devices Nipro Renal Solutions Corporation USA MedicaPure™ Liquid Acid Concentrate (K901471) Diasol, Inc. Dryasol Acid Concentrate Mix (K993212) Nipro Renal Solutions Corporation USA MedicaLyte™ Bicarbonate Powder (K131202) ________________________________________… | 1999 |
| * | K131202 | Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder (45X)…Summary page 4…Acid Concentrate (K901471) Diasol, Inc. Dryasol Acid Concentrate Mix (K993212) Nipro Renal Solutions Corporation USA MedicaLyte™ Bicarbonate Powder (K131202) ________________________________________ 510(k) Premarket Notification for Nipro Renal Solutions Corporation USA K193155 – Nipr… | 2014 |
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 35 years and passes through 3 companies; a new generation was cleared every 29.2 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K901471.
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?
For DA-100 series: This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyteTM bicarbonate, in a 36.83X three-stream artificial kidney (hemodialysis) machine. -or- For DA-200 series: This acid concentrate product is formulated for use in acute…
Read the full statement (161 words)
For DA-100 series:
This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyteTM bicarbonate, in a 36.83X three-stream artificial kidney (hemodialysis) machine.
-or-
For DA-200 series:
This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyteTM bicarbonate, in a 45X three-stream artificial kidney (hemodialysis) machine.
-or-
For DA-300 series:
This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyteTM bicarbonate, in a 35X three-stream artificial kidney (hemodialysis) machine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193155: Nipro Dry Complete Dry Acid Concentrate for Hemodialysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193155
Report an extraction error
Are you the manufacturer?
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