# K241424: InnoCare Specialty Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innocare Urologics, LLC
- Decided: Sep 18, 2024 after 121 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K896053 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142635: Medline Silicone Foley Catheter, Medline Industries, Inc. (2015) Summary page 5.

## Indications for use
The InnoCare Specialty Foley Catheter is intended for urethral catheterization for urological bladder drainage. The device is indicated for adult use only with a maximum indwell time of no more than 30 days.

Source page: https://510kreport.com/device/K241424
Methodology: https://510kreport.com/methodology