← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

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

DEVICE CLASS
Class II
REGULATION
21 CFR 876.5860
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
13
510(K)/PMA CLEARANCES
510k: 13
0
RECALL ENTRIES

Recent clearances

K252377Fresenius Medical Care Renal Therapies Group, LLC · 510k2026-05-15
K260533Nipro Medical Corporation · 510k2026-03-19
K252459Fresenius Medical Care Renal Therapies Group, LLC · 510k2026-02-10
K253412Outset Medical, Inc. · 510k2026-01-26
K253518Fresenius Medical Care Renal Therapies Group, LLC · 510k2025-12-18
K243920Medica USA, Inc. · 510k2025-09-19
K250508Vantive US Healthcare, LLC · 510k2025-08-01
K243237Fresenius Medical Care Renal Therapies Group, LLC · 510k2025-06-13

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →