# K254143: EM-TECH Passive Ultrasound Probe Strap

- Pathway: 510(k) (Traditional)
- Applicant: EM-TECH Solutions, Inc.
- Decided: Aug 10, 2026 after 231 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: 3 generations back to K974588 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092164: Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers, Model Ems-9UA, Shenzhen Delicate Electronics Co., Ltd. (2010) Summary page 6.

## Indications for use
The EM-TECH Passive Ultrasound Probe Strap is intended to passively secure an ultrasound transducer against a patient’s body during diagnostic ultrasound examinations performed by trained medical professionals. The device is intended for use in adult patients only.

Source page: https://510kreport.com/device/K254143
Methodology: https://510kreport.com/methodology