# K181445: AMSure Hydrophilic Intermittent Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Amsino International, Inc.
- Decided: Oct 1, 2018 after 122 days
- Product code: EZD (Catheter, Straight)
- 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: 5 generations back to K896729 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132500: Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric, Cure Catheter Hydrophilic Coated, Cure Medical, LLC (2013) Summary page 5.
- K091306: Amsure PVC Intermittent Catheter, Amsino International, Inc. (2009) Summary page 5.

## Indications for use
The AMSure® Hydrophilic Intermittent Catheter is inserted into the patient’s bladder and indicated for intermittent use for the purpose of drainage of urine from the bladder. The catheter does not contain a balloon on its tip. An optional Water sachet is included to activate the hydrophilic-coated surface prior to use. The target populations for the subject device are Adults and Pediatrics.

Source page: https://510kreport.com/device/K181445
Methodology: https://510kreport.com/methodology