Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Fresenius Medical Care Renal Therapies Group, LLC · Predicate Candidate Screening
52 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
148 daysmedian FDA review time
270 days90th percentile
52clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261267 | Careflux H60;Careflux H70;Careflux V500 | Fresenius Medical Care Renal Therapies Group, LLC | 2026-07-24 | 99 | 0 |
| K252377 | NxStage System One with NxView | Fresenius Medical Care Renal Therapies Group, LLC | 2026-05-15 | 289 | 0 |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-02-10 | 189 | 0 |
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-01-29 | 114 | 0 |
| K253518 | FX CorAL 40; FX CorAL 50 | Fresenius Medical Care Renal Therapies Group, LLC | 2025-12-18 | 36 | 0 |
| K250634 | BCM2-Body Composition Monitor | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-24 | 266 | 0 |
| K250471 | AquaC UNO H | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-14 | 269 | 0 |
| K251851 | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-10-09 | 115 | 0 |
| K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP | Fresenius Medical Care Renal Therapies Group, LLC | 2025-09-09 | 60 | 0 |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bib | Fresenius Medical Care Renal Therapies Group, LLC | 2025-06-13 | 246 | 0 |
| K243505 | 5008X Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | 2025-05-30 | 199 | 2 |
| K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP | Fresenius Medical Care Renal Therapies Group, LLC | 2025-04-04 | 116 | 2 |
| K250404 | stay•safe® catheter extension set with Safe- Lock, 12 inch; | Fresenius Medical Care Renal Therapies Group, LLC | 2025-04-03 | 50 | 0 |
| K242053 | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-03-21 | 252 | 0 |
| K243874 | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 1 | Fresenius Medical Care Renal Therapies Group, LLC | 2025-02-28 | 73 | 0 |
| K232953 | AquaBplus; AquaB LITE | Fresenius Medical Care Renal Therapies Group, LLC | 2024-06-13 | 266 | 0 |
| K240394 | multiFlux 1000 (F00012408) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-05-31 | 113 | 0 |
| K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW | Fresenius Medical Care Renal Therapies Group, LLC | 2024-05-10 | 148 | 1 |
| K232926 | Novalung ultimate kit (US) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-04-15 | 208 | 0 |
| K231125 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2023-12-06 | 230 | 4 |
| K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pure | Fresenius Medical Care Renal Therapies Group, LLC | 2023-12-01 | 65 | 0 |
| K213992 | CombiSet Hemodialysis Blood Tubing Set | Fresenius Medical Care Renal Therapies Group, LLC | 2023-05-31 | 526 | 0 |
| K220721 | FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX Cor | Fresenius Medical Care Renal Therapies Group, LLC | 2023-05-11 | 423 | 0 |
| K220281 | multiFiltratePRO System | Fresenius Medical Care Renal Therapies Group, LLC | 2022-12-16 | 318 | 0 |
| K222318 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2022-10-31 | 90 | 1 |
| K222952 | 2008T BlueStar Hemodailysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2022-10-27 | 30 | 12 |
| K212620 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Co | Fresenius Medical Care Renal Therapies Group, LLC | 2022-05-12 | 267 | 0 |
| K212522 | Lilliput APD System | Fresenius Medical Care Renal Therapies Group, LLC | 2022-04-15 | 247 | 0 |
| K203062 | Optiflux Series of Dialyzers F160NR, F180NR, F200NR | Fresenius Medical Care Renal Therapies Group, LLC | 2020-12-28 | 80 | 0 |
| K192707 | Optiflux F180NR Dialyzer | Fresenius Medical Care Renal Therapies Group, LLC | 2020-09-21 | 360 | 0 |
| K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attache | Fresenius Medical Care Renal Therapies Group, LLC | 2020-09-18 | 136 | 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 |
| K191407 | Novalung System | Fresenius Medical Care Renal Therapies Group, LLC | 2020-02-21 | 269 | 1 |
| K190459 | Hemoflow F3 and F4 Dialyzers | Fresenius Medical Care Renal Therapies Group, LLC | 2019-08-23 | 178 | 0 |
| K182367 | DIASAFEplusUS | Fresenius Medical Care Renal Therapies Group, LLC | 2019-01-10 | 132 | 0 |
| K181108 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-24 | 27 | 0 |
| K173593 | stay•safe catheter extension set with Safe-Lock, 12 inch, st | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-21 | 181 | 5 |
| K173972 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-10 | 132 | 13 |
| K173718 | Liberty Cycler Set | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-01 | 147 | 0 |
| K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, s | Fresenius Medical Care Renal Therapies Group, LLC | 2018-02-14 | 78 | 0 |
| K173363 | Cycler Drain Bag Set | Fresenius Medical Care Renal Therapies Group, LLC | 2018-01-24 | 90 | 0 |
| K172238 | CAREline Airless Hemodialysis Blood Tubing Sets | Fresenius Medical Care Renal Therapies Group, LLC | 2017-12-14 | 141 | 0 |
| K171652 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2017-09-15 | 102 | 0 |
| K162716 | bibag | Fresenius Medical Care Renal Therapies Group, LLC | 2017-05-18 | 231 | 0 |
| K153449 | 2008K2 Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2016-04-26 | 148 | 1 |
| K160749 | CRIT-LINE III Blood Chamber II | Fresenius Medical Care Renal Therapies Group, LLC | 2016-04-15 | 28 | 0 |
| K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, | Fresenius Medical Care Renal Therapies Group, LLC | 2015-12-10 | 266 | 8 |
| K141281 | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER | Fresenius Medical Care Renal Therapies Group, LLC | 2014-08-14 | 90 | 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