# K851684: Urotec/Franklin Soft Simplastic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Urotec Systems Corp.
- Decided: Jul 2, 1985 after 70 days
- Product code: KOD (Catheter, Urological)
- 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K963993: Rusch Simplastic Foley Catheterization Set (1996), 4 descendants of its own
- K162989: Rusch Simplastic Foley Catheters (2017), 2 descendants of its own
- K212077: Teleflex Rusch SoftSimplastic Foley Catheters (2023), 1 descendant of its own
- K252537: Rusch SoftSimplastic Foley Catheters (2026), 0 descendants of its own
- K082919: UC-Care Positioning System (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K851684
Methodology: https://510kreport.com/methodology