# K070048: Guardian Catheter-Infant Urinary Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Marian Medical, Inc.
- Decided: Mar 15, 2007 after 71 days
- Product code: FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit))
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The GuardianCatheter-Infant Urinary Collection Kit is for urinary drainage and collection for use in the neonatal/pediatric patient population.

Source page: https://510kreport.com/device/K070048
Methodology: https://510kreport.com/methodology