I-125 Seeds Code 6702

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K915156 ↗

FDA Product Code

KXK

Device Class

Class II

Regulation

21 CFR Part 892.5730

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Krypton Masks & Tubing

  Class II

  FDA 510(k) K811118 Active Cleared 2 Jun 1981

• I-125 Seeds, Code: 6711

  Class II

  FDA 510(k) K914281 Active Cleared 22 Nov 1991

• Sdmo Applicator Code: ASN.8236

  Class I

  FDA 510(k) K921961 Active Cleared 1 Jul 1992

• I-125 Rapid Strand

  Class II

  FDA 510(k) K940632 Active Cleared 2 Sep 1994

• I-125 Seeds in Carrier, Code: 6720

  Class II

  FDA 510(k) K914268 Active Cleared 22 Nov 1991

• Krypton Cart

  Class I

  FDA 510(k) K811677 Active Cleared 2 Jul 1981

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• What is the primary clinical use for these I-125 seeds, and why are they considered a precision treatment option?

  The I-125 seeds are designed for brachytherapy, a form of internal radiation therapy used to treat localized cancers, most commonly prostate cancer. They emit low-energy gamma radiation from iodine-125, allowing precise delivery of radiation directly to the tumor site while minimizing exposure to surrounding healthy tissue. This targeted approach enhances treatment accuracy and reduces side effects compared to external radiation methods.

• Are these seeds reusable, or are they intended for single-use only? How does this affect handling and safety?

  These I-125 seeds are sterile and intended for single-use only, requiring no reprocessing. This design ensures patient safety by preventing contamination or degradation from reuse, while also simplifying inventory management and reducing the risk of cross-contamination in clinical settings. Single-use also aligns with radiation safety protocols, as reprocessing could compromise the integrity of the radioactive source.

• What regulatory pathway was followed for FDA clearance, and how does this relate to their classification as a Class II device?

  The I-125 seeds were cleared via a traditional 510(k) pathway (K915156) submitted in 1991, demonstrating substantial equivalence to a predicate device. They are classified as a Class II medical device (FDA code 892.5730) due to their role in delivering radiation therapy, which requires special controls to ensure safety and effectiveness. The 510(k) process confirms that the device meets performance standards for brachytherapy applications while adhering to FDA regulations for radiologic devices.

• How should these seeds be stored, and what precautions should be taken given their radioactive nature?

  While the storage instructions aren’t explicitly detailed in the provided data, radioactive seeds like these must be stored in a secure, shielded container to prevent accidental exposure. They should be kept in a radiation-safe vault or lead-lined storage as per institutional protocols, away from unauthorized personnel. Handling requires adherence to radiation safety guidelines, including proper shielding, monitoring, and disposal procedures to comply with regulatory and occupational safety standards.