# K181672: SureTouch Mobile Pressure Mapping System

- Pathway: 510(k) (Traditional)
- Applicant: Sure, Inc.
- Decided: Jun 28, 2019 after 368 days
- Product code: NKA (System, Documentation, Breast Lesion)
- 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
Longest line of descent: 1 generation back to DEN020001 (2003). 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)
- DEN020001: Breastview Visual Mapping System, Assurance Medical (2003) Summary page 4.

## Indications for use
The SureTouch Mobile Pressure Mapping System is intended to produce a surface pressure map of the breast as an aid in documenting palpable breast lesions identified during a clinical breast examination. The SureTouch Mobile Pressure Mapping System is intended for use by a qualified healthcare professional trained in its use and is not for home use.

Source page: https://510kreport.com/device/K181672
Methodology: https://510kreport.com/methodology