# K850571: I-125 Implant Gun

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Mar 26, 1985 after 41 days
- Product code: IWJ (System, Applicator, Radionuclide, Manual)
- Device class: 1
- Regulation: 21 CFR 892.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972672: Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support and Manual Adjustment Accessory (1997), 6 descendants of its own
- K131161: EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch, Micro-Touch LP, Mulit-Purpose Workstation, (2013), 1 descendant of its own
- K982696: Interplant (1999), 1 descendant of its own
- K171040: Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range (2017), 0 descendants of its own
- K131428: Radvision (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K850571
Methodology: https://510kreport.com/methodology