# K060125: Sonic Palpometer

- Pathway: 510(k) (Traditional)
- Applicant: Palpometer Systems, Inc.
- Decided: Mar 16, 2006 after 57 days
- Product code: IKE (Transducer, Miniature Pressure)
- Device class: 1
- Regulation: 21 CFR 890.1615
- 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. The FDA summary names no predicate by number.

## Indications for use
The intended use of the Sonic Palpometer is to assess patient sensitivity to tactile stimulus by providing quantification of fingertip pressure, for tactile response procedures and treatments that use digital palpation.

Source page: https://510kreport.com/device/K060125
Methodology: https://510kreport.com/methodology