# K251402: LIA-1 Catheter (542-1)

- Pathway: 510(k) (Traditional)
- Applicant: Leadoptik, Inc.
- Decided: Dec 19, 2025 after 227 days
- Product code: KTI (Bronchoscope Accessory)
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K894632 (1989). 69 ancestors in all.
No later device cites it as a predicate yet.
2 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193517: ViziShot 2 FLEX, Olympus Surgical Technologies America (2020) Summary page 5.

## Indications for use
The LIA-1 Catheter is intended for use through a compatible bronchoscope in the tracheobronchial tree for Optical Coherence Tomography (OCT) guided Fine Needle Aspiration (FNA) and Fine Needle Biopsy (FNB) of endobronchial lesions, peripheral lung nodules, and lung masses. The device collects real-time two-dimensional, cross-sectional depth images which are visualized for evaluation of human tissue microstructure on the LIA Console. Do not use this device for any purpose other than its intended use. This device is intended to provide an image of tissue microstructure in the tracheobronchial tree and parenchyma. The safety and effectiveness of this device for diagnostic analysis (i.e., differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.

Source page: https://510kreport.com/device/K251402
Methodology: https://510kreport.com/methodology