# K182066: O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Oct 30, 2018 after 90 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 K970021 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132890: Suprapubic Catheter and Introducer Set, Mediplus, Ltd. (2014) Summary page 4.

## Indications for use
The O’Brien Suprapubic Peel-Away Access Set is used for introducing a drainage catheter suprapubically into the bladder. The Cook® SP Tube Introducer Set is used for introducing a drainage catheter suprapubically into the bladder.

Source page: https://510kreport.com/device/K182066
Methodology: https://510kreport.com/methodology