510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K900125Substantially Equivalent

Arteriovenous Fistula Sets

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

K900125 is the FDA 510(k) clearance record for ARTERIOVENOUS FISTULA SETS, a class II device, cleared for Baxter Healthcare Corp on under FDA product code FIE (Needle, Fistula). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K900125.

Clearance record

Decision date
Received
(22 days to decision)
Product code
FIE Needle, Fistula
Regulation
21 CFR 876.5540
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 FIE

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