510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211035Substantially Equivalent

U9000 Plus Ultrafilter

Baxter Healthcare Corporation, Round Lake IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211035 is the FDA 510(k) clearance record for U9000 Plus Ultrafilter, a class II device, cleared for Baxter Healthcare Corporation on under FDA product code FIP (Subsystem, Water Purification). FDA records list 570 510(k) clearances for Baxter Healthcare Corporation, from to . As of , FDA records show no recalls naming K211035.

Clearance record

Decision date
Received
(195 days to decision)
Product code
FIP Subsystem, Water Purification
Regulation
21 CFR 876.5665
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Baxter Healthcare Corporation 25212 W. Illinois Rte. 120, Round Lake IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FIP

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