# K162989: Rusch Simplastic Foley Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Feb 24, 2017 after 120 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- 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: 3 generations back to K984084 (1999). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963993: Rusch Simplastic Foley Catheterization Set, Rusch, Inc. (1996). Our reading of the summary gave K963996, FDA’s number for (Fsi) Laparoscopic Probe for All Fsi Ule FF101 Fibers.… (Full Spectrum, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Rusch Simplastic Foley Catheterization Set”. Summary page 5.
- K091699: Amsure Hydrophilic Latex Foley Catheter, Amsino International, Inc. (2009) Summary page 4.

## Most influential descendants
- K212077: Teleflex Rusch SoftSimplastic Foley Catheters (2023), 1 descendant of its own
- K252537: Rusch SoftSimplastic Foley Catheters (2026), 0 descendants of its own

## Indications for use
These catheters are indicated for routine transurethral drainage of the bladder or for routine post-operative transurethral drainage and irrigation of the bladder.

Source page: https://510kreport.com/device/K162989
Methodology: https://510kreport.com/methodology