# K080970: Ushifu Stepper

- Pathway: 510(k) (Traditional)
- Applicant: Ushifu Development Company, LLC
- Decided: Jun 11, 2008 after 68 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 K843573 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K843573: Civco-Super Scan/Biopsy Guide, CIVCO Medical Instruments Co., Inc. (1984) Summary page 1.

## Indications for use
The USHIFU Stepper is intended to provide support and stabilization for an ultrasonic probe during prostate imaging.

Source page: https://510kreport.com/device/K080970
Methodology: https://510kreport.com/methodology