# K972152: Devmed Stepping and Stabilizing System

- Pathway: 510(k) (Traditional)
- Applicant: Devmed Corp.
- Decided: Aug 15, 1997 after 67 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K802032 (1980). 5 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864807: Teknar Proscan (TM), Teknar, Inc. (1987) Summary page 1.
- K871413: Civco Stepper, CIVCO Medical Instruments Co., Inc. (1987) Summary page 1.
- K913293: Quick Seeder, Mick Radio-Nuclear Instruments, Inc. (1992) Summary page 1.
- K963302: Tayman Medical, Inc. Stepping & Stabilizing System, Tayman Medical, Inc. (1997) Summary page 1.
- K802032: Mini Mick Applicator, Mick Radio-Nuclear Instruments, Inc. (1980) Summary page 1.

## Most influential descendants
- K011581: Ameritek Brachytherapy Template (2001), 3 descendants of its own
- K031273: Ameritek Sure-Point HDR Needle Template (2003), 0 descendants of its own
- K030518: Ameritek Sure-Point Tracker System (2003), 0 descendants of its own
- K024183: Alton PT Stepper (2003), 0 descendants of its own

## Indications for use
The DevMed is designed to allow precision ultrasound probe alignment and radioactive seed.implantation.in brachytherapy treatments. A specific application. is the treatment-of prostate tancer.

Source page: https://510kreport.com/device/K972152
Methodology: https://510kreport.com/methodology