# K260009: LungPoint Virtual Bronchoscopic Navigation (VBN) Software

- Pathway: 510(k) (Traditional)
- Applicant: Broncus Medical, Inc.
- Decided: Apr 24, 2026 after 112 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K926514 (1993). 18 ancestors in all.
No later device cites it as a predicate yet.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090095: Lungpoint Virtual Bronchoscopic Navigation VBN System, Broncus Technologies, Inc. (2009) Summary page 5.

## Indications for use
The LungPoint Virtual Bronchoscopic Navigation (VBN) Software is indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract to a location in the tracheobronchial tree or lung tissue, and to enable marker placement within soft lung tissue in adults and pediatrics. It does not make a diagnosis and it is not an endoscopic tool.

Source page: https://510kreport.com/device/K260009
Methodology: https://510kreport.com/methodology