Rusch SoftSimplastic Foley Catheters

Q: What is the product code of K252537?

The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.

FDA 510(k) K252537 · Teleflex Medical Sdn. Bhd.

Substantially Equivalent

510(k) numberK252537

Submission

Device name: Rusch SoftSimplastic Foley Catheters
Applicant: Teleflex Medical Sdn. Bhd.
Kamunting, MY
Received: August 12, 2025
Decision date: January 20, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: EZL – Catheter, Retention Type, Balloon
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5130
Specialty: Gastroenterology, Urology

Other 510(k)s with product code EZL

510(k)	Device	Applicant	Decision
K260756	TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)EZL · Traditional	Sentinel Medical Technologies,	09/04/2026SE
K262056	Rusch Latex Gold Foley CatheterEZL · Traditional	Teleflex Medical Sdn. Bhd.	08/05/2026SE
K243011	Silicone Urethral Catheter (Silicone Urethral Catheter)EZL · Traditional	Guangdong Ecan Medical Co., Ltd.	06/16/2025SE
K241424	InnoCare Specialty Foley CatheterEZL · Traditional	Innocare Urologics, LLC	09/18/2024SE
K232469	Rüsch Latex Gold Foley CatheterEZL · Traditional	Teleflexmedical, Inc.	08/01/2024SE
K240057	TraumaGuard Intra-abdominal Pressure Sensing SystemEZL · Traditional	Sentinel Medical Technologies, LLC	04/17/2024SE
K233411	Folysil Silicone CatheterEZL · Traditional	Coloplast Corp.	04/15/2024SE
K233013	2-Way 100% Silicone Cleartract CatheterEZL · Traditional	Silq Technologies Corporation	01/23/2024SE
K212077	Teleflex Rusch SoftSimplastic Foley CathetersEZL · Traditional	Teleflexmedical, Inc.	07/27/2023SE
K231101	Flume CatheterEZL · Special	Flume Catheter Company, Ltd.	06/29/2023SE

More from Flume Catheter Company, Ltd.

510(k)	Device	Decision
K262056	Rusch Latex Gold Foley CatheterEZL · Traditional	08/05/2026SE
K252643	Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledCAH · Traditional	05/15/2026SE

Questions and answers

When was Rusch SoftSimplastic Foley Catheters cleared by the FDA?

Rusch SoftSimplastic Foley Catheters (K252537) received a 510(k) decision of Substantially Equivalent on January 20, 2026, 161 days after the submission was received.

What is the product code of K252537?

The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.