# K181814: AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water

- Pathway: 510(k) (Traditional)
- Applicant: Amsino International, Inc.
- Decided: Sep 4, 2018 after 57 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 K943836 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030813: Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile Water Catalog Numbers 1010 and, Primary Care Solutions, Inc. (2003) Summary page 4.

## Most influential descendants
- K200556: AquaFlate Pre-Filled Sterile Water Syringe 10mL (2020), 0 descendants of its own

## Indications for use
Pre-filled Syringe for Balloon Inflation with Sterile Water is intended to be used in inflating foley catheter balloon.

Source page: https://510kreport.com/device/K181814
Methodology: https://510kreport.com/methodology