510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K142635Substantially Equivalent

Medline Silicone Foley Catheter

MEDLINE INDUSTRIES, LP - Northfield, Mundelein IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142635 is the FDA 510(k) clearance record for Medline Silicone Foley Catheter, a class II device, cleared for Medline Industries, Inc. on under FDA product code EZL (Catheter, Retention Type, Balloon). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show one recall naming K142635.

Clearance record

Decision date
Received
(114 days to decision)
Product code
EZL Catheter, Retention Type, Balloon
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medline Industries, Inc. One Medline Pl., Mundelein IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EZL

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