510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K192034Substantially Equivalent

HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc

Pathway, LLC, Santee CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192034 is the FDA 510(k) clearance record for HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc, a class II device, cleared for Pathway, LLC on under FDA product code EZL (Catheter, Retention Type, Balloon). FDA records list 3 510(k) clearances for Pathway, LLC, from to . As of , FDA records show no recalls naming K192034.

Clearance record

Decision date
Received
(266 days to decision)
Product code
EZL Catheter, Retention Type, Balloon
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pathway, LLC 8779 Cottonwood Ave. Suite 105, Santee CA
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