# K963302: Tayman Medical, Inc. Stepping & Stabilizing System

- Pathway: 510(k) (Traditional)
- Applicant: Tayman Medical, Inc.
- Decided: Feb 6, 1997 after 168 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: 1 (0 Class I)
- 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; 5 cite 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. The FDA summary names its predicate without a number.
- (no number) Teknar, Inc. Seeding device: named in the summary without a submission number

## Most influential descendants
- K972152: Devmed Stepping and Stabilizing System (1997), 4 descendants of its own
- K011581: Ameritek Brachytherapy Template (2001), 3 descendants of its own
- K982696: Interplant (1999), 1 descendant of its own
- K131428: Radvision (2013), 0 descendants of its own
- K031273: Ameritek Sure-Point HDR Needle Template (2003), 0 descendants of its own

## Recalls of this device
- Nov 9, 2006 · Not classified · Z-0221-2007: The In/Out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient.

## Indications for use
The Tayman Medical, Inc. Stepping and Stabilization System is used to provide precision ultrasound probe alignment and radioactive seed implantation in the treatment of prostate cancer.

Source page: https://510kreport.com/device/K963302
Methodology: https://510kreport.com/methodology