# K071787: Bemitt, Model 0001

- Pathway: 510(k) (Traditional)
- Applicant: Dja Distributors, LLC
- Decided: Oct 26, 2007 after 116 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K955249 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023390: MY Breast Friend, Breast Self-Exam Pad, Mbf Sales, LLC (2002) Summary page 1.
- K042250: Sensatouch, Aluna Management Co., Ltd. (2004)

## Indications for use
The BeMittTM Self Breast Exam is indicated as an aid for performing breast-self examinations.

Source page: https://510kreport.com/device/K071787
Methodology: https://510kreport.com/methodology