Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KPO — Predicate Candidate Screening
123 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
269 days90th percentile
123clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-01-29 | 114 | 0 |
| K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP | Fresenius Medical Care Renal Therapies Group, LLC | 2025-09-09 | 60 | 0 |
| K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP | Fresenius Medical Care Renal Therapies Group, LLC | 2025-04-04 | 116 | 2 |
| K240920 | HemoCare Bicarbonate Concentrate Set (BCS) | Deka Research and Development | 2024-07-12 | 99 | 0 |
| K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW | Fresenius Medical Care Renal Therapies Group, LLC | 2024-05-10 | 148 | 1 |
| K233213 | NxStage PureFlow Solution | Nxstage Medical, Inc. | 2024-01-18 | 112 | 0 |
| K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pure | Fresenius Medical Care Renal Therapies Group, LLC | 2023-12-01 | 65 | 0 |
| K223431 | Citric Complete Liquid Citric Acid Concentrate | Nipro Renal Solutions USA, Corp. | 2023-08-04 | 263 | 0 |
| K221652 | NIKKICART | Renal Care Dialysis Solutions, S.A. DE C.V. | 2023-03-03 | 269 | 0 |
| K202508 | Hemo-Lyte C Cartridge | Di-Chem, Inc. | 2022-08-12 | 711 | 0 |
| K212620 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Co | Fresenius Medical Care Renal Therapies Group, LLC | 2022-05-12 | 267 | 0 |
| K212052 | HMB32 Dialysis Solution | Haemopharm Biofluids S.R.L. | 2021-07-23 | 23 | 0 |
| K193155 | Nipro Dry Complete Dry Acid Concentrate for Hemodialysis | Nipro Renal Solutions USA, Corp. | 2020-11-25 | 377 | 0 |
| K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrat | Fresenius Medical Care Renal Therapies Group, LLC | 2020-05-08 | 268 | 0 |
| K192017 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Co | Fresenius Medical Care Renal Therapies Group, LLC | 2020-04-24 | 270 | 0 |
| K191474 | NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLy | Fresenius Medical Care Renal Therapies Group, LLC | 2020-02-24 | 265 | 0 |
| K191093 | Isopure Dry Acid Dissolution System | Isopure, Corp. | 2020-01-22 | 272 | 0 |
| K180679 | CitriCon Liquid and Powder (Acid Concentrate acidified with | Global Scientific Technologies, LLC | 2018-12-07 | 267 | 0 |
| K171750 | Citric Complete Dry Citric Acid (45X) | Dimesol USA, LLC | 2018-03-06 | 266 | 1 |
| K171015 | Citryte | Di-Chem, Inc. | 2017-10-13 | 192 | 0 |
| K162716 | bibag | Fresenius Medical Care Renal Therapies Group, LLC | 2017-05-18 | 231 | 0 |
| K162887 | PrismaSATE | Baxter Healthcare Corporation | 2017-01-06 | 81 | 0 |
| K160847 | Rockwell Medical CitraPure Acid Concetrate | Rockwell Medical | 2016-10-20 | 206 | 0 |
| K150966 | HMB32 | Haemopharm Biofluids S.R.L. | 2015-12-04 | 235 | 0 |
| K131202 | MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BIC | Dialysis Medical Solutions, LLC | 2014-04-03 | 339 | 0 |
| K130511 | CITRISOL ACID CONCENTRATE | Diasol, Inc. | 2014-02-10 | 348 | 0 |
| K131611 | FRESENIUS DRY ACID DISSOLUTION UNITS | Fresenius Medical Care North America | 2013-08-29 | 87 | 0 |
| K120333 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEME | Gambro Renal Products | 2012-05-25 | 112 | 0 |
| K120005 | ACDS | Isopure, Corp. | 2012-03-29 | 86 | 2 |
| K102194 | SOLCART B | B. Braun Avitum AG | 2011-04-25 | 264 | 0 |
| K090002 | ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONC | Baxter Healthcare Corp | 2009-08-07 | 217 | 0 |
| K072908 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEME | Gambro Renal Products | 2008-02-04 | 115 | 1 |
| K072760 | SOLCART B | B. Braun Medizintechnologie GmbH | 2008-01-29 | 123 | 0 |
| K071387 | FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, | Fresenius Medical Care North America | 2007-06-15 | 28 | 6 |
| K070177 | FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND | Fresenius Medical Care North America | 2007-03-29 | 70 | 32 |
| K062399 | ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE | Rockwell Medical Technologies, Inc. | 2006-11-17 | 93 | 0 |
| K053286 | MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION | Nxstage Medical, Inc. | 2005-12-22 | 27 | 3 |
| K052393 | B. BRAUN MODIFIED BICARBONATE DIALYSATE | B.Braun Medical, Inc. | 2005-11-09 | 70 | 0 |
| K052253 | MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE | Gambro Renal Products | 2005-11-02 | 76 | 0 |
| K050827 | NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE | Dialysis Solutions, Inc. | 2005-08-22 | 143 | 0 |
| K042045 | NXSTAGE PUREFLOW-B SOLUTION | Nxstage Medical, Inc. | 2004-08-27 | 28 | 1 |
| K041683 | B. BRAUN BICARBONATE DIALYSATE | B.Braun Medical, Inc. | 2004-08-27 | 67 | 0 |
| K041428 | ACCUSOL DIALYSIS SOLUTION | Baxter Healthcare Corp | 2004-08-27 | 91 | 0 |
| K034066 | B.BRAUN PREMIXED DIALYSATE | B.Braun Medical, Inc. | 2004-03-03 | 63 | 0 |
| K033386 | NXSTAGE PUREFLOW SOLUTION | Nxstage Medical, Inc. | 2003-11-26 | 34 | 0 |
| K030497 | FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERI | Fresenius Medical Care | 2003-05-20 | 90 | 11 |
| K023985 | ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CO | Rockwell Medical Technologies, Inc. | 2003-02-28 | 88 | 0 |
| K022521 | BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 1 | Rockwell Medical Technologies, Inc. | 2003-01-03 | 157 | 2 |
| K022500 | DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE | Rockwell Medical Technologies, Inc. | 2002-12-23 | 147 | 0 |
| K020231 | DIASOL-ADDITIVES | Diasol, Inc. | 2002-10-21 | 271 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda