# K202698: Prefilled Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Primecare Medical Co., Ltd.
- Decided: Dec 15, 2020 after 90 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.
No later device cites it as a predicate yet.
1 of 3 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 5.

## Indications for use
The 10cc and 30cc pre-filled syringes are intended to be used for foley catheter balloon inflation.

Source page: https://510kreport.com/device/K202698
Methodology: https://510kreport.com/methodology