# K030813: Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile Water Catalog Numbers 1010 and

- Pathway: 510(k) (Traditional)
- Applicant: Primary Care Solutions, Inc.
- Decided: May 30, 2003 after 77 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 27 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943836 (1994). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943836: Pre-Filled 10CC Inflation Syringe W/Sterile Water, Orion Life Systems, Inc. (1994) Summary page 1.

## Most influential descendants
- K181814: AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water (2018), 1 descendant of its own
- K202698: Prefilled Syringe (2020), 0 descendants of its own
- K200556: AquaFlate Pre-Filled Sterile Water Syringe 10mL (2020), 0 descendants of its own

## Recalls of this device
- Nov 6, 2023 · Class I · Z-0515-2024: Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product
- Nov 6, 2023 · Class I · Z-0511-2024: Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product
- Jan 22, 2016 · Class II · Z-1212-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1223-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1209-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1224-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1219-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1227-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1218-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1221-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1210-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1226-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1229-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1220-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1228-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1211-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1215-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1222-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1203-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1214-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1206-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1208-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1213-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1205-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1225-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1216-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
- Jan 22, 2016 · Class II · Z-1217-2016: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

## Indications for use
A sterile water pre-filled syringe for use in inflating foley catheter balloon

Source page: https://510kreport.com/device/K030813
Methodology: https://510kreport.com/methodology