# K043246: Brachysource Brachytherapy Seed Implants

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Feb 2, 2005 after 71 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 1-1251 Implant Seed, STM 1251: named in the summary without a submission number

## Most influential descendants
- K093663: Radionuclide Brachytherapy Source (2009), 1 descendant of its own
- K140856: Brachysource Seed Implants with Sourcecap Bioabsorbable Caps (2014), 0 descendants of its own
- K060636: Palladium-103 Seed Implant Kits -Multiple (2006), 0 descendants of its own

## Recalls of this device
- Dec 9, 2016 · Class II · Z-0267-2018: Activity and quantity of seeds sent in shipments were incorrect.

## Indications for use
BrachySource® Seed Implants are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. BrachySource® 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/K043246
Methodology: https://510kreport.com/methodology