# K021938: Vitalcare Urethral Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vitalcare, Inc.
- Decided: Apr 22, 2003 after 314 days
- Product code: GBM (Catheter, Urethral)
- 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) Kendall Urethral Catheter: named in the summary without a submission number

## Indications for use
Vitalcare's Urethral Catheters are intended to be inserted through the urethra to the bladder and utilized for passage of fluid into the urinary tract.

Source page: https://510kreport.com/device/K021938
Methodology: https://510kreport.com/methodology