# K030120: Amsure Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Amsino International, Inc.
- Decided: Oct 29, 2003 after 289 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K091699: Amsure Hydrophilic Latex Foley Catheter (2009), 4 descendants of its own
- K162989: Rusch Simplastic Foley Catheters (2017), 2 descendants of its own
- K212077: Teleflex Rusch SoftSimplastic Foley Catheters (2023), 1 descendant of its own
- K252537: Rusch SoftSimplastic Foley Catheters (2026), 0 descendants of its own
- K101824: Amsure 3-Way Hydrophilic Latex Foley Catheter (2010), 0 descendants of its own

## Indications for use
The AMSure Foley Catheter is intended for use in the drainage of fluids to, and from, the urinary tract

Source page: https://510kreport.com/device/K030120
Methodology: https://510kreport.com/methodology