# K101824: Amsure 3-Way Hydrophilic Latex Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Amsino International, Inc.
- Decided: Sep 13, 2010 after 74 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: 3 generations back to K896053 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091699: Amsure Hydrophilic Latex Foley Catheter, Amsino International, Inc. (2009) Summary page 1.
- K030120: Amsure Foley Catheter, Amsino International, Inc. (2003) Summary page 1.
- K002868: Bard All-Silicone 3-Way Foley Catheter; Bard Lubri-Sil 3-Way Foley Catheter; Bard Lubri-Sil I.C. 3-Way Foley Catheter, C.R. Bard, Inc. (2000) Summary page 1.
- K082815: Well Lead Silicone and Latex Foley Catheters, Well Lead Medical Instruments (2008) Summary page 1.

## Indications for use
AMSURE 3-Way Hydrophilic Latex Foley Catheter is intended to be used for bladder/urinary tract drainage and bladder/urinary tract irrigation for urological use only.

Source page: https://510kreport.com/device/K101824
Methodology: https://510kreport.com/methodology