PharmaSeed BT-125-1
by Syncor Pharmaceuticals, Inc. 510(k)
Active
510(k) K992008
Overview
The PharmaSeed BT-125-1 is a Source, Brachytherapy, Radionuclide device, classified as a Class 2 Radiology product. It is designed for use in brachytherapy procedures, delivering localized radiation therapy through a sealed radioactive source. The device consists of a cylindrical palladium rod with precise dimensions, serving as the radiation-emitting element for targeted treatment applications in oncology.
This device is supplied as a single-use, non-sterile source intended for controlled medical environments. The cylindrical palladium rod measures 0.500 mm outer diameter and 3.25 mm length, with specifications derived from peer-reviewed studies. It is regulated under FDA 510(k) clearance (K992008) and falls under the Radiology specialty with product code KXK, adhering to regulatory standards for brachytherapy sources. Storage and handling must comply with radiation safety protocols to ensure proper use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992008 | Date23 Dec 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- Full name
- Pharmaseed, Model Bt-125-1
- 510(k) Number
- FDA Product Code
- KXK
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5730
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syncor Pharmaceuticals, Inc.
Questions
What is the PharmaSeed BT-125-1 used for?
The PharmaSeed BT-125-1 is designed specifically for brachytherapy procedures, delivering localized radiation therapy through a sealed radioactive source. Its cylindrical palladium rod emits radiation precisely to treat targeted areas in oncology, ensuring controlled and concentrated treatment for improved efficacy in cancer care.
Is the PharmaSeed BT-125-1 sterile and single-use?
The PharmaSeed BT-125-1 is supplied as a single-use device and is non-sterile. It is intended for use in controlled medical environments where sterility is not required for the specific application of brachytherapy. Always follow radiation safety protocols during handling and storage.
What are the dimensions of the palladium rod in the PharmaSeed BT-125-1?
The cylindrical palladium rod in the PharmaSeed BT-125-1 measures 0.500 mm in outer diameter and 3.25 mm in length. These precise specifications are derived from peer-reviewed studies to ensure accurate radiation delivery in brachytherapy treatments.
How should the PharmaSeed BT-125-1 be stored and handled?
Due to its radioactive nature, the PharmaSeed BT-125-1 must be stored and handled in strict compliance with radiation safety protocols. It is critical to follow manufacturer guidelines and institutional policies to minimize exposure risk, ensure proper containment, and maintain its integrity for intended use.
What regulatory clearance does the PharmaSeed BT-125-1 hold?
The PharmaSeed BT-125-1 is cleared under the FDA 510(k) pathway with clearance number K992008. It is classified as a Class 2 Radiology product under product code KXK, adhering to regulatory standards for brachytherapy sources. This clearance confirms its substantial equivalence to a predicate device.