# K200556: AquaFlate Pre-Filled Sterile Water Syringe 10mL

- Pathway: 510(k) (Traditional)
- Applicant: H R Pharmaceuticals, Inc.
- Decided: Mar 31, 2020 after 28 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 K943836 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181814: AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water, Amsino International, Inc. (2018) Summary page 4.

## Indications for use
The AquaFlate Pre-filled Sterile Water Syringe is intended to be used for inflating a Foley catheter balloon.

Source page: https://510kreport.com/device/K200556
Methodology: https://510kreport.com/methodology