# K010420: Rusch MMG/O'neil Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Rusch, Inc.
- Decided: May 9, 2001 after 86 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
32 later devices descend from it; 3 cite it directly.
0 of 33 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
- K080881: Cure Catheter Closed System (2008), 10 descendants of its own

## Recalls of this device
- Sep 20, 2022 · Class II · Z-0227-2023: Product may not be sterile
- Nov 22, 2016 · Class II · Z-0771-2017: Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.
- Jul 11, 2005 · Not classified · Z-1083-05: There is a lack of assurance of sterility for parts of these lots of product.

Source page: https://510kreport.com/device/K010420
Methodology: https://510kreport.com/methodology