# K042250: Sensatouch

- Pathway: 510(k) (Traditional)
- Applicant: Aluna Management Co., Ltd.
- Decided: Nov 12, 2004 after 84 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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 K955249 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973450: Sensor Pad, Inventive Products, Inc. (1997) Summary page 1.
- K023390: MY Breast Friend, Breast Self-Exam Pad, Mbf Sales, LLC (2002) Summary page 1.
- K991469: Aware Pad, Aac Consulting Group, Inc. (1999) Summary page 1.

## Most influential descendants
- K071787: Bemitt, Model 0001 (2007), 0 descendants of its own

## Indications for use
SensaTouchTM is indicated as an aid for performing breast self-examinations.

Source page: https://510kreport.com/device/K042250
Methodology: https://510kreport.com/methodology