# K901185: Foley Catheter Insertion Tray (10CC)

- Pathway: 510(k) (Traditional)
- Applicant: Orion Life Systems, Inc.
- Decided: Jul 20, 1990 after 129 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: 1 (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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jul 10, 2014 · Class III · Z-2154-2014: Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is correct, however the expiration date incorrectly indicates that the product is expired.

Source page: https://510kreport.com/device/K901185
Methodology: https://510kreport.com/methodology