# K093663: Radionuclide Brachytherapy Source

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 23, 2009 after 28 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K043246 (2005). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043246: Brachysource Brachytherapy Seed Implants, C.R. Bard, Inc. (2005) Summary page 1.

## Most influential descendants
- K140856: Brachysource Seed Implants with Sourcecap Bioabsorbable Caps (2014), 0 descendants of its own

## Recalls of this device
- Apr 10, 2018 · Class II · Z-1702-2018: Bard Medical Division is recalling the BARD¿ BrachySource¿ Iodine125 Radioactive Seeds in Mick¿ Applicators and BARD¿ BrachySource¿ Iodine125 Radioactive Seeds Loose in Vial with Sterile Spacers. Beca

## Indications for use
BrachySourcee Seed Implant's are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck,. lung, pancreas, and early stage prostate. Br achySource® Seed Implants may be used in superficial, intra-abdominal and intra-thoracic locations. BrachySource® Seed Implants are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.

Source page: https://510kreport.com/device/K093663
Methodology: https://510kreport.com/methodology