# K103349: Backstop Catheter

- Pathway: 510(k) (Abbreviated)
- Applicant: Pluromed, Inc.
- Decided: Jan 7, 2011 after 52 days
- Product code: KOD (Catheter, Urological)
- 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 K965229 (1997). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090270: Backstop Catheter, Model 60-0000-3100, Pluromed, Inc. (2009) Summary page 2.

## Most influential descendants
- K110491: Backstop Catheter (2011), 2 descendants of its own
- K180354: UroGen Ureteral Catheter (2018), 1 descendant of its own
- K211032: Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (2021), 0 descendants of its own

## Indications for use
The 3F Backstop Catheter is indicated for use by physicians for facilitating access to the urinary tract, either through a retrograde or an antegrade route, and may be used in conjunction with a guidewire or for the injection of gels, such as BackStop TM, or fluid into the urinary tract.

Source page: https://510kreport.com/device/K103349
Methodology: https://510kreport.com/methodology