# K181097: Cook Cystostomy Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jan 18, 2019 after 267 days
- Product code: KOB (Catheter, Suprapubic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K810368 (1981). 4 ancestors in all.
1 later device descends 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)
- K014002: All Silicone Supra-Pubia Catheter, Models 4880/4890, Fortune Medical Instrument Corp. (2002) Summary page 4.
- K140085: Universa Percultaneous  Drainage Catheter, Cook Incorporated (2014) Summary page 4.

## Most influential descendants
- K240514: AMT Low-Profile Suprapubic Catheter & Drainage Set (2024), 0 descendants of its own

## Indications for use
The Cook® Cystostomy Catheter Set is used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks.

Source page: https://510kreport.com/device/K181097
Methodology: https://510kreport.com/methodology