# K030712: Amsure Urethral Catheterization Tray

- Pathway: 510(k) (Traditional)
- Applicant: Amsino International, Inc.
- Decided: May 23, 2003 after 78 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K091306: Amsure PVC Intermittent Catheter (2009), 1 descendant of its own
- K181445: AMSure Hydrophilic Intermittent Catheter (2018), 0 descendants of its own
- K082831: Amself Closed Catheterization System (2008), 0 descendants of its own

## Indications for use
The MSure Urethral Catherization Tray is intended for use in the drainage of urine from the bladder.

Source page: https://510kreport.com/device/K030712
Methodology: https://510kreport.com/methodology