# K250524: Mendaera Guidance System

- Pathway: 510(k) (Traditional)
- Applicant: Mendaera, Inc.
- Decided: Jul 2, 2025 after 131 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K882383 (1988). 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)
- K160806: Verza Guidance System, CIVCO Medical Instruments Co., Inc. (2016) Summary page 5.

## Indications for use
The system provides guidance for precise instrument placement of common interventional devices by positioning the device relative to the ultrasound transducer and the resulting image during a diagnostic or therapeutic procedure. This guidance system is intended for use with pediatric and adult patients.

Source page: https://510kreport.com/device/K250524
Methodology: https://510kreport.com/methodology