# K014002: All Silicone Supra-Pubia Catheter, Models 4880/4890

- Pathway: 510(k) (Traditional)
- Applicant: Fortune Medical Instrument Corp.
- Decided: Mar 4, 2002 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K181097: Cook Cystostomy Catheter Set (2019), 1 descendant of its own
- K132890: Suprapubic Catheter and Introducer Set (2014), 1 descendant of its own
- K240514: AMT Low-Profile Suprapubic Catheter & Drainage Set (2024), 0 descendants of its own
- K182066: O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set (2018), 0 descendants of its own

## Indications for use
The Suprapubic Catheter is intended to use for drainage of the bladder through a needle puncture or stab wound over the bladder.

Source page: https://510kreport.com/device/K014002
Methodology: https://510kreport.com/methodology