# K963993: Rusch Simplastic Foley Catheterization Set

- Pathway: 510(k) (Traditional)
- Applicant: Rusch, Inc.
- Decided: Dec 17, 1996 after 74 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
Longest line of descent: 1 generation back to K851684 (1985). 1 ancestor in all.
4 later devices descend from it; 2 cite 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)
- K851684: Urotec/Franklin Soft Simplastic Catheter, Urotec Systems Corp. (1985) Summary page 2.
- (no number) Rusch Simplastic Foley Catheter (preamendment): named in the summary without a submission number

## Most influential descendants
- 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

## Indications for use
The Riasch Simplastic Foley Catheter is intended to be used to pass fluids to and from the urinary tract. A pack of lubricating jelly is intended to assist insertion of the catheter through the urethra.

Source page: https://510kreport.com/device/K963993
Methodology: https://510kreport.com/methodology