510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K093120Substantially Equivalent

Xenium Xpm 110, Xenium Xpm 130, Models M25649a, M25650a, Xenium Xpm 150, Xenium Xpm 170

Baxter Healthcare Corporation - Renal Division, Mcgaw Park IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093120 is the FDA 510(k) clearance record for XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170, a class II device, cleared for Baxter Healthcare Corporation - Renal Division on under FDA product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System). FDA records list 2 510(k) clearances for Baxter Healthcare Corporation - Renal Division, from to . As of , FDA records show no recalls naming K093120.

Clearance record

Decision date
Received
(138 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
Baxter Healthcare Corporation - Renal Division 1620 Waukegan Rd., Mcgaw Park IL
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