# K132890: Suprapubic Catheter and Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Mediplus, Ltd.
- Decided: Jan 17, 2014 after 123 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: 1 generation back to K970021 (1997). 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 1.
- K980919: All Silicone 2-Way & 3-Way Foly Balloon Catheter and Nelaton Catheter, Fortune Medical Instrument Corp. (1998) Summary page 1.
- K970021: Rusch Suprapubic Tray, Rusch, Inc. (1997) Summary page 3.
- K082536: Cook Wire Guides, Cook Urological, Inc. (2008) Summary page 7.

## Most influential descendants
- K182066: O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set (2018), 0 descendants of its own

## Indications for use
The Suprapubic Catheter and Introducer Set are indicated for drainage of the bladder through a needle puncture or stab wound over the bladder. For use no greater than 29 days.

Source page: https://510kreport.com/device/K132890
Methodology: https://510kreport.com/methodology