FDA Product Code
FDA Product Code KDI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5860
510(k) Clearances — 345 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261267 | Careflux H60;Careflux H70;Careflux V500 | Fresenius Medical Care Renal Therapies Group, LLC | 2026-07-24 | Traditional | PDF ↗ |
| K252377 | NxStage System One with NxView | Fresenius Medical Care Renal Therapies Group, LLC | 2026-05-15 | Traditional | PDF ↗ |
| K260533 | ELISIO-H | Nipro Medical Corporation | 2026-03-19 | Special | PDF ↗ |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-02-10 | Traditional | PDF ↗ |
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | Outset Medical, Inc. | 2026-01-26 | Traditional | PDF ↗ |
| K253518 | FX CorAL 40; FX CorAL 50 | Fresenius Medical Care Renal Therapies Group, LLC | 2025-12-18 | Special | PDF ↗ |
| K243920 | Purema H Hemoconcentrator - Pediatric | Medica USA, Inc. | 2025-09-19 | Traditional | PDF ↗ |
| K250508 | AK 98 Dialysis Machine (955607) | Vantive US Healthcare, LLC | 2025-08-01 | Traditional | PDF ↗ |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-06-13 | Traditional | PDF ↗ |
| K243505 | 5008X Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | 2025-05-30 | Traditional | PDF ↗ |
| K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | NIKKISO CO., LTD. | 2025-05-15 | Traditional | PDF ↗ |
| K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) | Sorin Group Italia S.R.L. | 2025-04-25 | Traditional | PDF ↗ |
| K242053 | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-03-21 | Traditional | PDF ↗ |
| K243874 | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-02-28 | Traditional | PDF ↗ |
| K233798 | Moda-flx Hemodialysis System and Cartridge | Diality, Inc. | 2024-08-02 | Traditional | PDF ↗ |
| K233557 | HemoCare Hemodialysis System | Deka Research and Development | 2024-07-12 | Traditional | PDF ↗ |
| K240394 | multiFlux 1000 (F00012408) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-05-31 | Special | PDF ↗ |
| K232776 | Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer | Outset Medical, Inc. | 2024-05-03 | Traditional | PDF ↗ |
| K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) | Nxstage Medical, Inc. | 2024-03-14 | Traditional | PDF ↗ |
| K232171 | Purema® H Hemoconcentrator (EtO Sterilized) | Tecnoideal America | 2024-02-07 | Traditional | PDF ↗ |
| K231534 | 5008X Hemodialysis System | Fresenius Medical Care | 2024-02-02 | Traditional | PDF ↗ |
| K231125 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2023-12-06 | Traditional | PDF ↗ |
| K233335 | Tablo® Hemodialysis System | Outset Medical, Inc. | 2023-12-05 | Traditional | PDF ↗ |
| K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis Machine | Baxter Healthcare Corporation | 2023-09-14 | Special | PDF ↗ |
| K230632 | VersiHD with GuideMe software | Nxstage Medical, Inc. | 2023-08-11 | Traditional | PDF ↗ |
| K223248 | Tablo® Hemodialysis System | Outset Medical, Inc. | 2023-06-21 | Traditional | PDF ↗ |
| K231406 | ClearumTM HS | Bellco Srl | 2023-06-14 | Special | PDF ↗ |
| K220721 | FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 | Fresenius Medical Care Renal Therapies Group, LLC | 2023-05-11 | Traditional | PDF ↗ |
| K220281 | multiFiltratePRO System | Fresenius Medical Care Renal Therapies Group, LLC | 2022-12-16 | Traditional | PDF ↗ |
| K222067 | SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set | Quanta Dialysis Technologies, Ltd. | 2022-11-10 | Traditional | PDF ↗ |
| K222952 | 2008T BlueStar Hemodailysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2022-10-27 | Traditional | PDF ↗ |
| K211370 | Tablo Hemodialysis System | Outset Medical, Inc. | 2022-07-29 | Traditional | PDF ↗ |
| K210575 | HDF Assist Mudule, HDF Infusion Set and Substitution Filter | Nephros | 2022-05-13 | Traditional | PDF ↗ |
| K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set | Baxter Healthcare Corporation | 2022-04-01 | Traditional | PDF ↗ |
| K213639 | Revaclear 500, Revaclear 400, Revaclear 300 | Baxter Healthcare Corporation | 2022-01-24 | Traditional | PDF ↗ |
| K210661 | SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset | Quanta Dialysis Technologies, Ltd. | 2021-08-12 | Traditional | PDF ↗ |
| K201809 | AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory | Baxter Healthcare Corportation | 2021-03-10 | Traditional | PDF ↗ |
| K203062 | Optiflux Series of Dialyzers F160NR, F180NR, F200NR | Fresenius Medical Care Renal Therapies Group, LLC | 2020-12-28 | Traditional | PDF ↗ |
| K193670 | SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set | Quanta Dialysis Technologies, Ltd. | 2020-12-23 | Traditional | PDF ↗ |
| K193542 | Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 | Bellco Srl | 2020-10-08 | Traditional | PDF ↗ |
| K192707 | Optiflux F180NR Dialyzer | Fresenius Medical Care Renal Therapies Group, LLC | 2020-09-21 | Traditional | PDF ↗ |
| K193005 | DIMI RRT System | Dialco Medical, Inc. | 2020-08-28 | Traditional | PDF ↗ |
| K192928 | Optiflux Enexa F500 Dialyzer | Fresenius Medical Care Reanal Therapies Group, LLC | 2020-07-09 | Traditional | PDF ↗ |
| K200741 | Tablo Hemodialysis System | Outset Medical, Inc. | 2020-03-31 | Traditional | PDF ↗ |
| K193482 | PrisMax System Version 3 | Baxter Healthcare Corporation | 2020-03-13 | Traditional | PDF ↗ |
| K192756 | Aquadex FlexFlow System 2.0 | Chf Solutions, Inc. | 2020-02-24 | Traditional | PDF ↗ |
| K190793 | Tablo Hemodialysis System, Tablo Cartridge | Outset Medical, Inc. | 2019-12-12 | Traditional | PDF ↗ |
| K183158 | NxStage Cartridge Express with Speedswap | Nxstage Medical, Inc. | 2019-08-09 | Traditional | PDF ↗ |
| K190910 | PrisMax System Version 2 | Baxter Healthcare Corp | 2019-07-25 | Traditional | PDF ↗ |
| K182940 | Surdial DX Hemodialysis System | Nipro Medical Corporation | 2019-07-19 | Traditional | PDF ↗ |
| K173972 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-10 | Traditional | PDF ↗ |
| K171671 | Prismaflex System 8.10 | Baxter Healthcare Corporation | 2018-02-23 | Traditional | PDF ↗ |
| K170790 | SAM CRRT Unit, SAM Cassette CRRT | Spectral Medical, Inc. | 2017-12-13 | Abbreviated | PDF ↗ |
| K171331 | NxStage System One | Nxstage Medical, Inc. | 2017-08-24 | Traditional | PDF ↗ |
| K170574 | Diacap Pro Dialyzer | B. Braun Avitum AG | 2017-08-11 | Traditional | PDF ↗ |
| K170469 | NxStage System One Plus | Nxstage Medical, Inc. | 2017-05-09 | Traditional | PDF ↗ |
| K162248 | Asahi ViE-U Series Dialyzer | Asahi Kasei Medical Co., Ltd. | 2017-05-03 | Traditional | PDF ↗ |
| K163530 | PrisMax Control Unit | Baxter Healthcare Corp | 2017-05-03 | Traditional | PDF ↗ |
| K162488 | Optiflux dialyzer | Fresenius Medical Care North America | 2017-04-06 | Traditional | PDF ↗ |
| K160444 | FB-U Hemodialyzer | Nipro Medical Corporation | 2017-02-08 | Traditional | PDF ↗ |
| K160558 | RAPIDO HOLLOW-FIBRE DIALYZERS | Bellco Srl | 2016-11-18 | Traditional | PDF ↗ |
| K160881 | Tablo Console | Outset Medical, Inc. | 2016-11-15 | Traditional | PDF ↗ |
| K153449 | 2008K2 Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2016-04-26 | Traditional | PDF ↗ |
| K152938 | DBB-06 Hemodialysis Delivery System | NIKKISO CO., LTD. | 2016-03-18 | Traditional | PDF ↗ |
| K143482 | xevonta dialyzer | B. Braun Avitum AG | 2016-03-01 | Traditional | PDF ↗ |
| K153344 | Asahi REXEED-S Series Dialyzer | Asahi Kasei Medical Co., Ltd. | 2015-12-17 | Special | PDF ↗ |
| K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2015-12-10 | Traditional | PDF ↗ |
| K152367 | Optiflux dialyzer | Fresenius Medical Care North America | 2015-10-29 | Traditional | PDF ↗ |
| K150880 | Tablo Console with Wireless Capability | Outset Medical | 2015-05-01 | Special | PDF ↗ |
| K143313 | NxStage Therapeutic Plasma Exchange (TPE) Cartridge | Nxstage Medical, Inc. | 2015-03-20 | Traditional | PDF ↗ |
| K140866 | TABLO CONSOLE | Home Dialysis Plus | 2014-09-10 | Traditional | PDF ↗ |
| K133299 | ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY | Fresenius Medical Care, North America - Renal Ther | 2014-07-07 | Traditional | PDF ↗ |
| K140526 | NXSTAGE SYSTEM ONE | Nxstage Medical, Inc. | 2014-05-19 | Traditional | PDF ↗ |
| K140191 | ELISIO-H HEMODIALYZER | Nipro Medical Corporation | 2014-04-14 | Special | PDF ↗ |
| K133547 | NXSTAGE SYSTEM ONE WITH NXVIEW | Nxstage Medical, Inc. | 2014-03-03 | Traditional | PDF ↗ |
| K132602 | STREAMLINE EXPRESS | Nxstage Medical, Inc. | 2014-02-04 | Traditional | PDF ↗ |
| K123262 | OPTIFLUX ULTRA DIALYZER | Fresenius Medical Care North America | 2014-01-06 | Traditional | PDF ↗ |
| K131516 | PRISMAFLEX SYSTEM 7.10 | Gambro Renal Products, Inc. | 2014-01-03 | Traditional | PDF ↗ |
| K131050 | NXSTAGE 1.6M2 DIALYZER | Nxstage Medical, Inc. | 2013-12-27 | Traditional | PDF ↗ |
| K131935 | ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER | Nipro Medical Corporation | 2013-12-20 | Special | PDF ↗ |
| K131381 | ELISIO-H HEMODIALYZER | Nipro Medical Corporation | 2013-12-19 | Special | PDF ↗ |
| K131908 | 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) | Fresenius Medical Care Renal Therapies Group, LLC | 2013-10-11 | Traditional | PDF ↗ |
| K123288 | HEMOCONCENTRATOR | Maquet Cardiopulmonary, AG | 2013-06-26 | Traditional | PDF ↗ |
| K122343 | PUREFLUX-H HEMODIALYZER | Nipro Medical Corporation | 2013-05-07 | Traditional | PDF ↗ |
| K130039 | REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER | Gambro Renal Products, Inc. | 2013-05-02 | Traditional | PDF ↗ |
| K122347 | ELISIO-H AND ELISIO-M HEMODIALYZERS | Nipro Medical Corporation | 2013-05-01 | Traditional | PDF ↗ |
| K122051 | NXSTAGE SYSTEM ONE | Nxstage Medical, Inc. | 2013-04-23 | Special | PDF ↗ |
| K123395 | NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS | Nxstage Medical, Inc. | 2013-03-07 | Traditional | PDF ↗ |
| K121409 | ASAHI REXEED-SX/LX SERIES DIALYZER | Asahi Kasei Medical Co., Ltd. | 2013-02-06 | Traditional | PDF ↗ |
| K113023 | STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER | Nxstage Medical, Inc. | 2012-12-21 | Traditional | PDF ↗ |
| K121341 | FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM | Fresenius Medical Care North America | 2012-12-06 | Traditional | PDF ↗ |
| K121497 | VENOFER PUMP | Renal Solutions, Inc. | 2012-08-17 | Traditional | PDF ↗ |
| K112314 | NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER | Nephros, Inc. | 2012-04-27 | Traditional | PDF ↗ |
| K120505 | FRESENIUS 2008T HEMODIALYSIS MACHINE | Fresenius Medical Care North America, Design Cente | 2012-03-06 | Special | PDF ↗ |
| K120017 | FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM | Fresenius Medical Care North America | 2012-02-02 | Special | PDF ↗ |
| K113427 | FRESENIUS 2008T HEMODIALYSIS MACHINE | Fresenius Medical Care North America | 2011-12-21 | Special | PDF ↗ |
| K111639 | FRESENIUS 2008T HEMODIALYSIS MACHINE | Fresenius Medical Care | 2011-10-21 | Special | PDF ↗ |
| K110823 | PRISMAFLEX | Gambro Renal Products, Inc. | 2011-06-17 | Traditional | PDF ↗ |
| K103832 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM | Gambro Renal Products, Inc. | 2011-05-20 | Traditional | PDF ↗ |
| K103564 | VENOFER PUMP | Renal Solutions, Inc. | 2011-02-10 | Special | PDF ↗ |
Product code KDI · Class II · Gastroenterology, Urology. Data: openFDA.