# K142330: Kobold Ring and Tandem Applicator Set

- Pathway: 510(k) (Traditional)
- Applicant: Kobold, LLC
- Decided: Apr 9, 2015 after 232 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K864210 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123912: Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator Set, Spencer Fillmore (2013) Summary page 6.

## Indications for use
The CT Compatible / MR Unsafe HDR Kobold Ring and Tandem Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus is accepted by up-to-date clinical guidelines. The Kobold Ring and Tandem Applicator Set is intended for continuous use of up to 24 hours of contact with patient.

Source page: https://510kreport.com/device/K142330
Methodology: https://510kreport.com/methodology