FDA product code KPO: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
KPO is the FDA product code for dialysate concentrate for hemodialysis (liquid or powder). It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 124 510(k) submissions under KPO, 12 in the last five years, from 68 different applicants. The average 510(k) review took 141 days (median 90); 115 days on average over the last three years. FDA has posted 113 recalls for KPO devices, 25 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for KPO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 168 |
| 2018 | 2 | 266 |
| 2020 | 5 | 290 |
| 2021 | 1 | 23 |
| 2022 | 2 | 489 |
| 2023 | 3 | 199 |
| 2024 | 3 | 120 |
| 2025 | 2 | 88 |
| 2026 | 2 | 138 |
Compare with all 510(k) review times · Search every KPO clearance
Top KPO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fresenius Medical Care Renal Therapies Group, LLC | 10 | 2026-01-29 |
| Nxstage Medical, Inc. | 6 | 2024-01-18 |
| Gambro Renal Products | 6 | 2012-05-25 |
| Baxter Healthcare Corp | 6 | 2009-08-07 |
| Di-Chem, Inc. | 5 | 2022-08-12 |
63 more applicants have KPO clearances. See the full list in Caduvo.
Most recent KPO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260799 | Nipro Technical Solutions, Incoporated | Nipro Dry Acid Concentrate Mixer | 2026-08-19 | 161 |
| K253462 | Fresenius Medical Care Renal Therapies Group, LLC | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | 2026-01-29 | 114 |
| K252180 | Fresenius Medical Care Renal Therapies Group, LLC | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) | 2025-09-09 | 60 |
| K243786 | Fresenius Medical Care Renal Therapies Group, LLC | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) | 2025-04-04 | 116 |
| K240920 | Deka Research and Development | HemoCare Bicarbonate Concentrate Set (BCS) | 2024-07-12 | 99 |
Recalls for KPO devices
113 product recalls in 45 recall events; 25 initiated in the last five years and 56 still open. Most recent: 2026-08-05.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 13 |
| 2019 | 3 |
| 2020 | 32 |
| 2021 | 4 |
| 2022 | 6 |
| 2024 | 2 |
| 2025 | 8 |
| 2026 | 9 |
Frequently asked questions
What is FDA product code KPO?
KPO is the FDA product code for dialysate concentrate for hemodialysis (liquid or powder). It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is KPO?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code KPO?
Across 124 cleared submissions the average was 141 days from receipt to decision (median 90).
Which companies have the most KPO clearances?
Fresenius Medical Care Renal Therapies Group, LLC (10); Nxstage Medical, Inc. (6); Gambro Renal Products (6); Baxter Healthcare Corp (6); Di-Chem, Inc. (5).
Have KPO devices been recalled?
Yes: 113 product recalls across 45 recall events; the most recent began 2026-08-05.
Next steps
- Run an FDA pathway report with predicate devices for product code KPO
- Run a recall and safety report across every KPO manufacturer
- Watch product code KPO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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