# K110752: Highland Instruments Ces and Tus Instrument Holder

- Pathway: 510(k) (Traditional)
- Applicant: Highland Instruments
- Decided: Jun 28, 2011 after 102 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: 1 generation back to K002533 (2000). 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)
- K002533: TCD 100M, PWD13 Transducer, Spencer Technologies (2000) Summary page 1.
- (no number) Civco Assist Positioning Arm System with Ultrasound Transducer Holder: named in the summary without a submission number

## Indications for use
The Highland Instruments CBS and TUS Instrument Holder is intended for use in assisting holding and securing commercially available CBS electrodes and diagnostic Transcranial Ultrasound System Probes in the desired position on the patient's head.

Source page: https://510kreport.com/device/K110752
Methodology: https://510kreport.com/methodology