# K091699: Amsure Hydrophilic Latex Foley Catheter

- Pathway: 510(k) (Special)
- Applicant: Amsino International, Inc.
- Decided: Aug 10, 2009 after 61 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: 2 generations back to K984084 (1999). 6 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030120: Amsure Foley Catheter, Amsino International, Inc. (2003) Summary page 1.
- K040658: Bardex I.C. Latex Foley Catheter, C.R. Bard, Inc. (2004) Summary page 1.
- K070508: Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FR, C.R. Bard, Inc. (2007) Summary page 1.
- K984084: Bardex Lubri-Sil Foley Catheter, Bard Medical Div. (1999) Summary page 1.

## Most influential descendants
- 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 AMSUREeHYDROPHILIC LATEX FOLEY CATHETER, is intendedfor use in the drainage offluids from, and to the urinary tract/bladder.

Source page: https://510kreport.com/device/K091699
Methodology: https://510kreport.com/methodology