510(k) K192209
- Device
- Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
- 510(k) number
- K192209
- Product code
- KPO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-05-08
- Date received
- 2019-08-14
- Regulation
- 876.5820
- Classification name
- Dialysate Concentrate For Hemodialysis (liquid Or Powder)
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Denise Oppermann
- Address
- 920 Winter St. Waltham MA US 02451 02451
FDA Registration Numbers#
- 3005162618
- 3032828299
- 3010242164
- 9611823
- 9610270
- 3038195011
- 1225714
- 3019131
- 1528807
- 1954315
- 9610725
- 3003768032
- 3027241826
- 3035708507
- 1651896
- 3016096143
- 3043014136
- 2029275
- 3003591774
- 9616277
- 1652176
- 2183415
- 1056186
- 8030639
- 1713747
- 3003464075
- 3007137482
- 3013764800
- 3027592507
- 2431908
- 1835498
- 3013546115
- 3012364195
- 3005578748
- 3004176176
Source Documents#
Other 510(k) Records For Product Code KPO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-01-29 |
| K252180 | 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) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-09-09 |
| K243786 | 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) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-04-04 |
| K240920 | HemoCare Bicarbonate Concentrate Set (BCS) | Deka Research and Development | 2024-07-12 |
| K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-05-10 |
| K233213 | NxStage PureFlow Solution | Nxstage Medical, Inc. | 2024-01-18 |
| K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 | Fresenius Medical Care Renal Therapies Group, LLC | 2023-12-01 |
| K223431 | Citric Complete Liquid Citric Acid Concentrate | Nipro Renal Solutions USA, Corp. | 2023-08-04 |
| K221652 | NIKKICART | Renal Care Dialysis Solutions, S.A. DE C.V. | 2023-03-03 |
| K202508 | Hemo-Lyte C Cartridge | Di-Chem, Inc. | 2022-08-12 |
| K212620 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | 2022-05-12 |
| K212052 | HMB32 Dialysis Solution | Haemopharm Biofluids S.R.L. | 2021-07-23 |
| K193155 | Nipro Dry Complete Dry Acid Concentrate for Hemodialysis | Nipro Renal Solutions USA, Corp. | 2020-11-25 |
| K192017 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | 2020-04-24 |
| K191474 | NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-02-24 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases