# K022861: Safetouch

- Pathway: 510(k) (Traditional)
- Applicant: Rusin Medical Devices
- Decided: Nov 26, 2002 after 90 days
- Product code: NHM (Sheet, Recording, Breast Examination)
- Device class: 2
- Regulation: 21 CFR 884.2990
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The SafeTouch sheet and marking pen are used to mark the location of breast lumps that a woman may find while doing her monthly breast self-examination.

Source page: https://510kreport.com/device/K022861
Methodology: https://510kreport.com/methodology