# K082264: Contura Lumen Marker

- Pathway: 510(k) (Traditional)
- Applicant: Senorx, Inc.
- Decided: Sep 12, 2008 after 32 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K864210 (1986). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060349: Proguide Needle Set, Nucletron Corporation (2006) Summary page 1.
- K071229: Senorad Multi-Lumen Balloon Source Applicator for Branchytherapy, Senorx, Inc. (2007) Summary page 1.
- (no number) Nucletron CT Marker: named in the summary without a submission number

## Indications for use
The Contura Lumen Marker is an accessory to the Contura MLB Applicator intended to be used to identify treatment lumens for radiation therapy dose planning.

Source page: https://510kreport.com/device/K082264
Methodology: https://510kreport.com/methodology