# K161392: Elation Pulmonary Balloon Dilation

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Sep 1, 2016 after 105 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: 1 generation back to K023337 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have 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 4.

## Most influential descendants
- K213434: Elation Pulmonary Balloon Dilation Catheter (2022), 0 descendants of its own

## Indications for use
The Elation™ Pulmonary Balloon Dilation Catheter is intended to be used to endoscopically dilate strictures of the trachea and bronchi.

Source page: https://510kreport.com/device/K161392
Methodology: https://510kreport.com/methodology