# K961442: Universal Drainage Tray

- Pathway: 510(k) (Traditional)
- Applicant: Customed, Inc.
- Decided: May 9, 1996 after 24 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: 2 (0 Class I)
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Dec 8, 2011 · Not classified · Z-1254-2012: The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condit
- Dec 8, 2011 · Not classified · Z-1257-2012: The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condit

Source page: https://510kreport.com/device/K961442
Methodology: https://510kreport.com/methodology