# K053595: Curay Custom Seed Array

- Pathway: 510(k) (Traditional)
- Applicant: Biolucent, Inc.
- Decided: Feb 28, 2006 after 67 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- 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 K801748 (1980). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043596: Theraload Custom Loaded Needles, Models 200 and 125.S06, Theragenics Corp. (2005) Summary page 1.
- K023073: Seed Link, Implant Sciences Corp. (2003) Summary page 1.
- K023179: Readi-Strand, Model Psstrand, Worldwide Medical Technologies, LLC (2003) Summary page 1.
- K030594: I-125 Rapid Strand, Model 7000, Amersham Health (2003) Summary page 1.
- (no number) Nag Brachyflex Catheters (Cook, Inc.): named in the summary without a submission number

## Indications for use
CuRay Custom Seed Array is a sterile, custom loaded, brachytherapy seed assembly intended to treat localized tumors such as tumors of the head, neck, lung, pancreas, breast, uterus, cervix and prostate. It can be used either as primary treatment or for residual disease after excision of the primary tumor or for recurring tumors. It may also be used concurrent with or at the completion of other treatment modalities such as external beam radiation therapy or chemotherapy.

Source page: https://510kreport.com/device/K053595
Methodology: https://510kreport.com/methodology