Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KDI — Predicate Candidate Screening
345 FDA 510(k) clearances under this product code; the 50 most recent screened below.
125 daysmedian FDA review time
381 days90th percentile
345clearances 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 |
| K260533 | ELISIO™-H | Nipro Medical Corporation | 2026-03-19 | 30 | 0 |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-02-10 | 189 | 0 |
| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U) | Outset Medical, Inc. | 2026-01-26 | 118 | 0 |
| K253518 | FX CorAL 40; FX CorAL 50 | Fresenius Medical Care Renal Therapies Group, LLC | 2025-12-18 | 36 | 0 |
| K243920 | Purema H Hemoconcentrator - Pediatric | Medica USA, Inc. | 2025-09-19 | 273 | 0 |
| K250508 | AK 98 Dialysis Machine (955607) | Vantive US Healthcare, LLC | 2025-08-01 | 161 | 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 |
| K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | NIKKISO CO., LTD. | 2025-05-15 | 296 | 0 |
| K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator | Sorin Group Italia S.R.L. | 2025-04-25 | 192 | 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 |
| K233798 | Moda-flx Hemodialysis System and Cartridge | Diality, Inc. | 2024-08-02 | 247 | 0 |
| K233557 | HemoCare Hemodialysis System | Deka Research and Development | 2024-07-12 | 249 | 0 |
| K240394 | multiFlux 1000 (F00012408) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-05-31 | 113 | 0 |
| K232776 | Tablo® Hemodialysis System; TabloCart™ with Prefiltration Dr | Outset Medical, Inc. | 2024-05-03 | 235 | 1 |
| K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR | Nxstage Medical, Inc. | 2024-03-14 | 184 | 0 |
| K232171 | Purema® H Hemoconcentrator (EtO Sterilized) | Tecnoideal America | 2024-02-07 | 201 | 0 |
| K231534 | 5008X Hemodialysis System | Fresenius Medical Care | 2024-02-02 | 248 | 1 |
| K231125 | 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2023-12-06 | 230 | 4 |
| K233335 | Tablo® Hemodialysis System | Outset Medical, Inc. | 2023-12-05 | 67 | 3 |
| K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis Machine | Baxter Healthcare Corporation | 2023-09-14 | 30 | 1 |
| K230632 | VersiHD with GuideMe software | Nxstage Medical, Inc. | 2023-08-11 | 157 | 0 |
| K223248 | Tablo® Hemodialysis System | Outset Medical, Inc. | 2023-06-21 | 243 | 0 |
| K231406 | ClearumTM HS | Bellco Srl | 2023-06-14 | 30 | 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 |
| K222067 | SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood | Quanta Dialysis Technologies, Ltd. | 2022-11-10 | 120 | 0 |
| K222952 | 2008T BlueStar Hemodailysis Machine | Fresenius Medical Care Renal Therapies Group, LLC | 2022-10-27 | 30 | 12 |
| K211370 | Tablo Hemodialysis System | Outset Medical, Inc. | 2022-07-29 | 451 | 1 |
| K210575 | HDF Assist Mudule, HDF Infusion Set and Substitution Filter | Nephros | 2022-05-13 | 441 | 0 |
| K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 | Baxter Healthcare Corporation | 2022-04-01 | 259 | 3 |
| K213639 | Revaclear 500, Revaclear 400, Revaclear 300 | Baxter Healthcare Corporation | 2022-01-24 | 67 | 0 |
| K210661 | SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood | Quanta Dialysis Technologies, Ltd. | 2021-08-12 | 161 | 0 |
| K201809 | AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Ch | Baxter Healthcare Corportation | 2021-03-10 | 252 | 0 |
| K203062 | Optiflux Series of Dialyzers F160NR, F180NR, F200NR | Fresenius Medical Care Renal Therapies Group, LLC | 2020-12-28 | 80 | 0 |
| K193670 | SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Bloo | Quanta Dialysis Technologies, Ltd. | 2020-12-23 | 358 | 0 |
| K193542 | Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, H | Bellco Srl | 2020-10-08 | 293 | 0 |
| K192707 | Optiflux F180NR Dialyzer | Fresenius Medical Care Renal Therapies Group, LLC | 2020-09-21 | 360 | 0 |
| K193005 | DIMI RRT System | Dialco Medical, Inc. | 2020-08-28 | 305 | 0 |
| K192928 | Optiflux Enexa F500 Dialyzer | Fresenius Medical Care Reanal Therapies Group, LLC | 2020-07-09 | 266 | 0 |
| K200741 | Tablo Hemodialysis System | Outset Medical, Inc. | 2020-03-31 | 8 | 0 |
| K193482 | PrisMax System Version 3 | Baxter Healthcare Corporation | 2020-03-13 | 87 | 2 |
| K192756 | Aquadex FlexFlow System 2.0 | Chf Solutions, Inc. | 2020-02-24 | 147 | 1 |
| K190793 | Tablo Hemodialysis System, Tablo Cartridge | Outset Medical, Inc. | 2019-12-12 | 259 | 1 |
| K183158 | NxStage Cartridge Express with Speedswap | Nxstage Medical, Inc. | 2019-08-09 | 267 | 1 |
| K190910 | PrisMax System Version 2 | Baxter Healthcare Corp | 2019-07-25 | 108 | 3 |
| K182940 | Surdial DX Hemodialysis System | Nipro Medical Corporation | 2019-07-19 | 269 | 1 |
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