# K131234: Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon)

- Pathway: 510(k) (Traditional)
- Applicant: Broncus Medical, Inc.
- Decided: Oct 15, 2013 after 167 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- 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: 2 generations back to K931154 (1993). 3 ancestors in all.
5 later devices descend from it; 4 cite it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023337: Cre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310, M00550320, M00550330, M00550340, M00550350, Boston Scientific Corp (2002) Summary page 1.
- K060243: Olympus Guide Sheath, Model XBO1-836-13, Olympus Medical Systems Corporation (2006) Summary page 1.

## Most influential descendants
- K142934: CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved (2015), 2 descendants of its own
- K260565: SmartClip Delivery Catheter (ADR-1715) (2026), 0 descendants of its own
- K232601: BroncTru™ Transbronchial Access Tool (2024), 0 descendants of its own
- K200702: EasyPath RF Introducer Sheath (2021), 0 descendants of its own
- K150280: PulmoVia Working Channel (2015), 0 descendants of its own

## Indications for use
The LungPoint Tools are endoscopic tools intended to be used with LungPoint Software guided bronchoscopes. The LungPoint Sheath is intended to be used as a working channel through which endoscopic tools may be introduced to targeted tissue. The LungPoint Dilation Balloon is intended to dilate tissue of the bronchial tree and may be inserted through the LungPoint Sheath or directly through the working channel of the bronchoscope. Not for pediatric use.

Source page: https://510kreport.com/device/K131234
Methodology: https://510kreport.com/methodology