510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113227Substantially Equivalent

Non-Dehp Micro-Volume Extension Set with 0.22 Micron Filter

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

K113227 is the FDA 510(k) clearance record for NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER, a class II device, cleared for Baxter Healthcare Corp on under FDA product code FPB (Filter, Infusion Line). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K113227.

Clearance record

Decision date
Received
(37 days to decision)
Product code
FPB Filter, Infusion Line
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Baxter Healthcare Corp 1 Baxter Pkwy., Deerfield IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FPB

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