510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K890315Substantially Equivalent

Capillary Flow Dialyzers Models Ct110g & Ct190g

Baxter Healthcare Corporation, Round Lake IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890315 is the FDA 510(k) clearance record for CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G, a class II device, cleared for Baxter Healthcare Corp on under FDA product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K890315.

Clearance record

Decision date
Received
(16 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 Corp Rte. 120 And Wilson Rd., Round Lake IL
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