# K142355: Vaginal Tactile Imager

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Tactile Imaging, Inc.
- Decided: May 28, 2015 after 276 days
- Product code: HIR (Perineometer)
- Device class: 2
- Regulation: 21 CFR 884.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011472 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031169: Motility Visualization System, Sierra Scientific Instruments, Inc. (2003) Summary page 4.
- K983052: Peritron Perineometer Model 9300V or 9300A, Cardio Design Pty., Ltd. (1998) Summary page 4.

## Most influential descendants
- K231875: Vaginal Tactile Ultrasound Imager (2024), 0 descendants of its own

## Indications for use
The Vaginal Tactile Imager obtains a high resolution mapping of pressures and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical setting to acquire the pressures and store the corresponding data. It also provides visualization, analysis tools and information. The real time data as well the analysis information can then be viewed with an intention of assisting in the diagnosis and evaluation. The device is intended for use by physicians, surgeons and medically trained personnel.

Source page: https://510kreport.com/device/K142355
Methodology: https://510kreport.com/methodology