# K003873: Mentor Self-Cath Closed System

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Corp.
- Decided: Mar 29, 2001 after 104 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.
27 later devices descend from it; 6 cite it directly.
0 of 28 devices 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.

## Most influential descendants
- K013483: Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus Kit (2002), 20 descendants of its own
- K090960: Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, (2009), 15 descendants of its own
- K110862: Vapro Plus Intermittent Catheter (2011), 14 descendants of its own
- K141642: Vapro Intermittent Catheter (2014), 13 descendants of its own
- K180824: VaPro 2 Intermittent Catheter (2018), 6 descendants of its own

Source page: https://510kreport.com/device/K003873
Methodology: https://510kreport.com/methodology