Atlas FDA

KDI

345 FDA 510(k) clearances · Product code

125 daysmedian time to decision
381 days90th percentile
345clearances measured

FDA profile

Official device name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5860
Medical specialty
Gastroenterology, Urology
Flags
Life-sustaining
Adverse events (MAUDE)
2021: 1,944 · 2022: 2,180 · 2023: 2,692 · 2024: 2,441 · 2025: 2,822 · 2026: 1,479
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Careflux H60;Careflux H70;Careflux V500 (K261267)Fresenius Medical Care Renal Therapies Group, LLC2026-07-24
NxStage System One with NxView (K252377)Fresenius Medical Care Renal Therapies Group, LLC2026-05-15
ELISIO™-H (K260533)Nipro Medical Corporation2026-03-19
multiFlux 130 (F00013123); multiFlux 160 (F00013124) (K252459)Fresenius Medical Care Renal Therapies Group, LLC2026-02-10
Tablo Hemodialysis System (PN-0008000, PN-0006000U) (K253412)Outset Medical, Inc.2026-01-26
FX CorAL 40; FX CorAL 50 (K253518)Fresenius Medical Care Renal Therapies Group, LLC2025-12-18
Purema H Hemoconcentrator - Pediatric (K243920)Medica USA, Inc.2025-09-19
AK 98 Dialysis Machine (955607) (K250508)Vantive US Healthcare, LLC2025-08-01
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) (K243237)Fresenius Medical Care Renal Therapies Group, LLC2025-06-13
5008X Hemodialysis System (K243505)Fresenius Medical Care Renal Therapies Group, LLC2025-05-30
DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (K242155)NIKKISO CO., LTD.2025-05-15
DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) (K243264)Sorin Group Italia S.R.L.2025-04-25
FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (K242053)Fresenius Medical Care Renal Therapies Group, LLC2025-03-21
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) (K243874)Fresenius Medical Care Renal Therapies Group, LLC2025-02-28
Moda-flx Hemodialysis System and Cartridge (K233798)Diality, Inc.2024-08-02
HemoCare Hemodialysis System (K233557)Deka Research and Development2024-07-12
multiFlux 1000 (F00012408) (K240394)Fresenius Medical Care Renal Therapies Group, LLC2024-05-31
Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer (K232776)Outset Medical, Inc.2024-05-03
NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) (K232803)Nxstage Medical, Inc.2024-03-14
Purema® H Hemoconcentrator (EtO Sterilized) (K232171)Tecnoideal America2024-02-07
5008X Hemodialysis System (K231534)Fresenius Medical Care2024-02-02
2008T BlueStar Hemodialysis Machine (K231125)Fresenius Medical Care Renal Therapies Group, LLC2023-12-06
Tablo® Hemodialysis System (K233335)Outset Medical, Inc.2023-12-05
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine (K232467)Baxter Healthcare Corporation2023-09-14
VersiHD with GuideMe software (K230632)Nxstage Medical, Inc.2023-08-11
Tablo® Hemodialysis System (K223248)Outset Medical, Inc.2023-06-21
ClearumTM HS (K231406)Bellco Srl2023-06-14
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 (K220721)Fresenius Medical Care Renal Therapies Group, LLC2023-05-11
multiFiltratePRO System (K220281)Fresenius Medical Care Renal Therapies Group, LLC2022-12-16
SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set (K222067)Quanta Dialysis Technologies, Ltd.2022-11-10
2008T BlueStar Hemodailysis Machine (K222952)Fresenius Medical Care Renal Therapies Group, LLC2022-10-27
Tablo Hemodialysis System (K211370)Outset Medical, Inc.2022-07-29
HDF Assist Mudule, HDF Infusion Set and Substitution Filter (K210575)Nephros2022-05-13
Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set (K212216)Baxter Healthcare Corporation2022-04-01
Revaclear 500, Revaclear 400, Revaclear 300 (K213639)Baxter Healthcare Corporation2022-01-24
SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset (K210661)Quanta Dialysis Technologies, Ltd.2021-08-12
AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory (K201809)Baxter Healthcare Corportation2021-03-10
Optiflux Series of Dialyzers F160NR, F180NR, F200NR (K203062)Fresenius Medical Care Renal Therapies Group, LLC2020-12-28
SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set (K193670)Quanta Dialysis Technologies, Ltd.2020-12-23
Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 (K193542)Bellco Srl2020-10-08
Optiflux F180NR Dialyzer (K192707)Fresenius Medical Care Renal Therapies Group, LLC2020-09-21
DIMI RRT System (K193005)Dialco Medical, Inc.2020-08-28
Optiflux Enexa F500 Dialyzer (K192928)Fresenius Medical Care Reanal Therapies Group, LLC2020-07-09
Tablo Hemodialysis System (K200741)Outset Medical, Inc.2020-03-31
PrisMax System Version 3 (K193482)Baxter Healthcare Corporation2020-03-13
Aquadex FlexFlow System 2.0 (K192756)Chf Solutions, Inc.2020-02-24
Tablo Hemodialysis System, Tablo Cartridge (K190793)Outset Medical, Inc.2019-12-12
NxStage Cartridge Express with Speedswap (K183158)Nxstage Medical, Inc.2019-08-09
PrisMax System Version 2 (K190910)Baxter Healthcare Corp2019-07-25
Surdial DX Hemodialysis System (K182940)Nipro Medical Corporation2019-07-19
2008T BlueStar Hemodialysis Machine (K173972)Fresenius Medical Care Renal Therapies Group, LLC2018-05-10
Prismaflex System 8.10 (K171671)Baxter Healthcare Corporation2018-02-23
SAM CRRT Unit, SAM Cassette CRRT (K170790)Spectral Medical, Inc.2017-12-13
NxStage System One (K171331)Nxstage Medical, Inc.2017-08-24
Diacap Pro Dialyzer (K170574)B. Braun Avitum AG2017-08-11
NxStage System One Plus (K170469)Nxstage Medical, Inc.2017-05-09
Asahi ViE-U Series Dialyzer (K162248)Asahi Kasei Medical Co., Ltd.2017-05-03
PrisMax Control Unit (K163530)Baxter Healthcare Corp2017-05-03
Optiflux dialyzer (K162488)Fresenius Medical Care North America2017-04-06
FB-U Hemodialyzer (K160444)Nipro Medical Corporation2017-02-08
RAPIDO HOLLOW-FIBRE DIALYZERS (K160558)Bellco Srl2016-11-18
Tablo Console (K160881)Outset Medical, Inc.2016-11-15
2008K2 Hemodialysis Machine (K153449)Fresenius Medical Care Renal Therapies Group, LLC2016-04-26
DBB-06 Hemodialysis Delivery System (K152938)NIKKISO CO., LTD.2016-03-18
xevonta dialyzer (K143482)B. Braun Avitum AG2016-03-01
Asahi REXEED-S Series Dialyzer (K153344)Asahi Kasei Medical Co., Ltd.2015-12-17
2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine (K150708)Fresenius Medical Care Renal Therapies Group, LLC2015-12-10
Optiflux dialyzer (K152367)Fresenius Medical Care North America2015-10-29
Tablo Console with Wireless Capability (K150880)Outset Medical2015-05-01
NxStage Therapeutic Plasma Exchange (TPE) Cartridge (K143313)Nxstage Medical, Inc.2015-03-20
TABLO CONSOLE (K140866)Home Dialysis Plus2014-09-10
ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY (K133299)Fresenius Medical Care, North America - Renal Ther2014-07-07
NXSTAGE SYSTEM ONE (K140526)Nxstage Medical, Inc.2014-05-19
ELISIO-H HEMODIALYZER (K140191)Nipro Medical Corporation2014-04-14
NXSTAGE SYSTEM ONE WITH NXVIEW (K133547)Nxstage Medical, Inc.2014-03-03
STREAMLINE EXPRESS (K132602)Nxstage Medical, Inc.2014-02-04
OPTIFLUX ULTRA DIALYZER (K123262)Fresenius Medical Care North America2014-01-06
PRISMAFLEX SYSTEM 7.10 (K131516)Gambro Renal Products, Inc.2014-01-03
NXSTAGE 1.6M2 DIALYZER (K131050)Nxstage Medical, Inc.2013-12-27
ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER (K131935)Nipro Medical Corporation2013-12-20
ELISIO-H HEMODIALYZER (K131381)Nipro Medical Corporation2013-12-19
2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) (K131908)Fresenius Medical Care Renal Therapies Group, LLC2013-10-11
HEMOCONCENTRATOR (K123288)Maquet Cardiopulmonary, AG2013-06-26
PUREFLUX-H HEMODIALYZER (K122343)Nipro Medical Corporation2013-05-07
REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER (K130039)Gambro Renal Products, Inc.2013-05-02
ELISIO-H AND ELISIO-M HEMODIALYZERS (K122347)Nipro Medical Corporation2013-05-01
NXSTAGE SYSTEM ONE (K122051)Nxstage Medical, Inc.2013-04-23
NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS (K123395)Nxstage Medical, Inc.2013-03-07
ASAHI REXEED-SX/LX SERIES DIALYZER (K121409)Asahi Kasei Medical Co., Ltd.2013-02-06
STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER (K113023)Nxstage Medical, Inc.2012-12-21
FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM (K121341)Fresenius Medical Care North America2012-12-06
VENOFER PUMP (K121497)Renal Solutions, Inc.2012-08-17
NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER (K112314)Nephros, Inc.2012-04-27
FRESENIUS 2008T HEMODIALYSIS MACHINE (K120505)Fresenius Medical Care North America, Design Cente2012-03-06
FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM (K120017)Fresenius Medical Care North America2012-02-02
FRESENIUS 2008T HEMODIALYSIS MACHINE (K113427)Fresenius Medical Care North America2011-12-21
FRESENIUS 2008T HEMODIALYSIS MACHINE (K111639)Fresenius Medical Care2011-10-21
PRISMAFLEX (K110823)Gambro Renal Products, Inc.2011-06-17
PHOENIX HEMODIALYSIS DELIVERY SYSTEM (K103832)Gambro Renal Products, Inc.2011-05-20
VENOFER PUMP (K103564)Renal Solutions, Inc.2011-02-10
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