# K031748: Vitalcare Sterilewater and 0.9% Sodium Chloride Pre-Filled 10CC/30CC Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Vitalcare Group, Inc.
- Decided: Aug 27, 2003 after 83 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Orion Life Systems Sterile Water and 0.9% 10cc pre-filled inflation syringes: named in the summary without a submission number

## Indications for use
Vitalcare Sterile Water and 0.9% Sodium Chloride. The 10cc/30cc syringes are used for balloon inflation. Devices are not intended for wound irrigation, injection or IV Administration.

Source page: https://510kreport.com/device/K031748
Methodology: https://510kreport.com/methodology