Chrysalis Intelligence · Product Codes · KDI

KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System

Gastroenterology, Urology · 46 clearances · 20 unique sponsors

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Device class
Class II
Regulation 876.5860
Total clearances
46
2020-02-24 → 2026-07-24
Last 12 months
7
Unique sponsors
20
Classification details
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.5860
Implant
N
Life-sustain / support
Y
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Fresenius Medical Care Renal Therapies Group, LLC 15 4 2026-07-24
Outset Medical, Inc. 6 1 2026-01-26
Baxter Healthcare Corporation 4 0 2023-09-14
Quanta Dialysis Technologies, Ltd. 3 0 2022-11-10
Nxstage Medical, Inc. 2 0 2024-03-14
Bellco Srl 2 0 2023-06-14
Chf Solutions, Inc. 1 0 2020-02-24
Nipro Medical Corporation 1 1 2026-03-19
Diality, Inc. 1 0 2024-08-02
Dialco Medical, Inc. 1 0 2020-08-28
Tecnoideal America 1 0 2024-02-07
Baxter Healthcare Corportation 1 0 2021-03-10
Sorin Group Italia S.R.L. 1 0 2025-04-25
Deka Research and Development 1 0 2024-07-12
Fresenius Medical Care 1 0 2024-02-02
Nephros 1 0 2022-05-13
Fresenius Medical Care Reanal Therapies Group, LLC 1 0 2020-07-09
NIKKISO CO., LTD. 1 0 2025-05-15
Medica USA, Inc. 1 1 2025-09-19
Vantive US Healthcare, LLC 1 0 2025-08-01
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
E1592 HCPCS Automatic intermittent peritoneal dialysis system ✓ CMS-verified description High HCPCS code for hemodialysis supplies; high permeability dialyzer
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-24 K261267 Fresenius Medical Care Renal Therapies Group, LLC Careflux H60;Careflux H70;Careflux V500
2026-05-15 K252377 Fresenius Medical Care Renal Therapies Group, LLC NxStage System One with NxView
2026-03-19 K260533 Nipro Medical Corporation ELISIO™-H
2026-02-10 K252459 Fresenius Medical Care Renal Therapies Group, LLC multiFlux 130 (F00013123); multiFlux 160 (F00013124)
2026-01-26 K253412 Outset Medical, Inc. Tablo Hemodialysis System (PN-0008000, PN-0006000U)
2025-12-18 K253518 Fresenius Medical Care Renal Therapies Group, LLC FX CorAL 40; FX CorAL 50
2025-09-19 K243920 Medica USA, Inc. Purema H Hemoconcentrator - Pediatric
2025-08-01 K250508 Vantive US Healthcare, LLC AK 98 Dialysis Machine (955607)
2025-06-13 K243237 Fresenius Medical Care Renal Therapies Group, LLC 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)
2025-05-30 K243505 Fresenius Medical Care Renal Therapies Group, LLC 5008X Hemodialysis System
2025-05-15 K242155 NIKKISO CO., LTD. DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
2025-04-25 K243264 Sorin Group Italia S.R.L. DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
2025-03-21 K242053 Fresenius Medical Care Renal Therapies Group, LLC FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)
2025-02-28 K243874 Fresenius Medical Care Renal Therapies Group, LLC 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)
2024-08-02 K233798 Diality, Inc. Moda-flx Hemodialysis System and Cartridge
2024-07-12 K233557 Deka Research and Development HemoCare Hemodialysis System
2024-05-31 K240394 Fresenius Medical Care Renal Therapies Group, LLC multiFlux 1000 (F00012408)
2024-05-03 K232776 Outset Medical, Inc. Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer
2024-03-14 K232803 Nxstage Medical, Inc. NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
2024-02-07 K232171 Tecnoideal America Purema® H Hemoconcentrator (EtO Sterilized)
2024-02-02 K231534 Fresenius Medical Care 5008X Hemodialysis System
2023-12-06 K231125 Fresenius Medical Care Renal Therapies Group, LLC 2008T BlueStar Hemodialysis Machine
2023-12-05 K233335 Outset Medical, Inc. Tablo® Hemodialysis System
2023-09-14 K232467 Baxter Healthcare Corporation CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
2023-08-11 K230632 Nxstage Medical, Inc. VersiHD with GuideMe software
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence