# K141806: Clear Guide One

- Pathway: 510(k) (Traditional)
- Applicant: Clear Guide Medical
- Decided: Sep 19, 2014 after 78 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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). 16 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121479: AIM, Inneroptic Technology, Inc. (2012) Summary page 4.

## Most influential descendants
- K211529: NAVIRFA Scope (2022), 0 descendants of its own
- K202119: AcuSee AS-P1000 System (2020), 0 descendants of its own

## Indications for use
The Clear Guide ONE is indicated for augmenting the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a display which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualization.

Source page: https://510kreport.com/device/K141806
Methodology: https://510kreport.com/methodology