510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K093902Substantially Equivalent

Modification To:fresenius 2008T Hemodialysis Machine, Model 190573

Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093902 is the FDA 510(k) clearance record for MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573, a class II device, cleared for Fresenius Medical Care North America on under FDA product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System). FDA records list 95 510(k) clearances for Fresenius Medical Care Renal Therapies Group, LLC, from to . As of , FDA records show 2 recalls naming K093902.

Clearance record

Decision date
Received
(156 days to decision)
Product code
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation
21 CFR 876.5860
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fresenius Medical Care North America 920 Winter St., Waltham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KDI

Trailing 12 months
6 clearances under product code KDI in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KDI, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20261
March 20261
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260