# K140099: Lighthouse Urinary Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Seedings Life Science Ventures, LLC
- Decided: Mar 4, 2014 after 47 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- 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: 5 generations back to K851659 (1985). 15 ancestors in all.
No later device cites it as a predicate yet.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131655: Lighthouse (TM) Urinary Catheter, Seedings Life Science Ventures, LLC (2013) Summary page 1.
- K042110: Beamcath, Beampoint AB (2005) Summary page 1.

## Indications for use
The Lighthouse TM Urinary Catheter is intended for bladder/urinary tract drainage during prostate biopsy and brachytherapy procedures where transrectal ultrasound (TRUS) imaging is used to visualize the prostate. The catheter additionally enhances identification of the course of the posterior aspect of the prostatic urethra during TRUS-guided prostate biopsy and brachytherapy procedures by creating an acoustic interface (i.e., air) between the catheter and the urethral wall via its urethral identification bladder.

Source page: https://510kreport.com/device/K140099
Methodology: https://510kreport.com/methodology