KDIFDA Class 2 · 21 CFR 876.5860
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device family · Gastroenterology, Urology
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
343
Manufacturers
35
Flagged signals
43
Adverse-event reports
35,638
Code matrix
| FDA product code | KDI |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5860 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | Yes |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2011 | 3 | 66.5 | 134 |
| Death | 2018 | 6 | 15.8 | 70 |
| Death | 2021 | 5 | 13.2 | 45 |
| Death | 2020 | 5 | 13.2 | 45 |
| Death | 2012 | 13 | 12.7 | 130 |
| Death | 2011 | 25 | 10.5 | 208 |
| Death | 2010 | 10 | 9.8 | 71 |
| Death | 2012 | 269 | 9.3 | 1,987 |
| Death | 2009 | 9 | 8.8 | 55 |
| Death | 2020 | 15 | 8.2 | 88 |
| Death | 2015 | 7 | 7.9 | 36 |
| Death | 2011 | 8 | 7.8 | 41 |
| Death | 2021 | 13 | 7.1 | 63 |
| Death | 2011 | 199 | 6.8 | 995 |
| Death | 2024 | 23 | 6.4 | 101 |
| Death | 2012 | 14 | 5.9 | 52 |
| 2011 | 3 | 5.7 | 7 | |
| Death | 2022 | 6 | 5.3 | 17 |
| Death | 2011 | 12 | 5.0 | 35 |
| Death | 2010 | 145 | 5.0 | 462 |
| Death | 2009 | 132 | 4.5 | 363 |
| Death | 2023 | 16 | 4.5 | 40 |
| Death | 2022 | 5 | 4.4 | 10 |
| Death | 2022 | 15 | 4.2 | 34 |
| Death | 2014 | 4 | 3.9 | 6 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 35,638 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| NXSTAGE MEDICAL, INC. | 26 | 2024 | — |
| Hospal Medical Corp. | 20 | 1989 | — |
| Baxter Healthcare Corp | 18 | 2019 | — |
| Fresenius Medical Care North America | 17 | 2017 | — |
| Fresenius Medical Care Renal Therapies Group, LLC | 17 | 2026 | — |
| Gambro, Inc. | 14 | 2009 | — |
| Outset Medical, Inc. | 8 | 2026 | — |
| NIPRO MEDICAL CORPORATION | 8 | 2026 | — |
| GAMBRO RENAL PRODUCTS, INC. | 8 | 2014 | — |
| Baxter Healthcare Corporation | 8 | 2023 | — |
| Fresenius Usa, Inc. | 6 | 1999 | — |
| NIKKISO CO., LTD. | 5 | 2025 | — |
| Asahi Kasei Medical Co., Ltd. | 5 | 2017 | — |
| Toray Industries (America), Inc. | 5 | 2003 | — |
| B. Braun Avitum AG | 4 | 2017 | — |
| BELLCO SRL | 3 | 2023 | — |
| National Medical Care, Medical Products Div., Inc. | 3 | 1992 | — |
| Terumo Medical Corp. | 3 | 2001 | — |
| Cobe Laboratories, Inc. | 2 | 1984 | — |
| Travenol Laboratories, S.A. | 2 | 1986 | — |
| Cordis Corp. | 2 | 1981 | — |
| NEPHROS, INC. | 2 | 2012 | — |
| Bentley Laboratories, Inc. | 2 | 1990 | — |
| Sorin Group Italia S.r.L. | 2 | 2025 | — |
| Erika, Inc. | 1 | 1985 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
ELISIO-H · Nipro Medical Corporation510(k) · 2026-03-19
multiFlux 130 (F00013123); multiFlux 160 (F00013124) · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2026-02-10
Tablo Hemodialysis System (PN-0008000, PN-0006000U) · Outset Medical, Inc.510(k) · 2026-01-26
FX CorAL 40; FX CorAL 50 · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2025-12-18
Purema H Hemoconcentrator - Pediatric · Medica USA, Inc.510(k) · 2025-09-19
AK 98 Dialysis Machine (955607) · Vantive US Healthcare, LLC510(k) · 2025-08-01
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) · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2025-06-13
5008X Hemodialysis System · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2025-05-30
DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) · NIKKISO CO., LTD.510(k) · 2025-05-15
DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) · Sorin Group Italia S.R.L.510(k) · 2025-04-25
FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2025-03-21
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) · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2025-02-28
Moda-flx Hemodialysis System and Cartridge · Diality, Inc.510(k) · 2024-08-02
HemoCare Hemodialysis System · Deka Research and Development510(k) · 2024-07-12
multiFlux 1000 (F00012408) · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2024-05-31
Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer · Outset Medical, Inc.510(k) · 2024-05-03
NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) · Nxstage Medical, Inc.510(k) · 2024-03-14
Purema® H Hemoconcentrator (EtO Sterilized) · Tecnoideal America510(k) · 2024-02-07
5008X Hemodialysis System · Fresenius Medical Care510(k) · 2024-02-02
2008T BlueStar Hemodialysis Machine · Fresenius Medical Care Renal Therapies Group, LLC510(k) · 2023-12-06
Tablo® Hemodialysis System · Outset Medical, Inc.510(k) · 2023-12-05
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine · Baxter Healthcare Corporation510(k) · 2023-09-14
VersiHD with GuideMe software · Nxstage Medical, Inc.510(k) · 2023-08-11
Tablo® Hemodialysis System · Outset Medical, Inc.510(k) · 2023-06-21
ClearumTM HS · Bellco Srl510(k) · 2023-06-14
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.