# K150951: aeris Balloon Dialation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bryan Medical, Inc.
- Decided: Jun 25, 2015 after 77 days
- Product code: KTI (Bronchoscope Accessory)
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K043527 (2005). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090660: Airway Balloon Catheter Inflation Device, Acclarent, Inc. (2009) Summary page 4.
- K023337: Cre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310, M00550320, M00550330, M00550340, M00550350, Boston Scientific Corp (2002) Summary page 4.

## Most influential descendants
- K231818: METIC™- Airway Balloon Catheter (2023), 0 descendants of its own

## Recalls of this device
- May 16, 2023 · Class II · Z-2148-2023: Devices were mislabeled.

## Indications for use
The aeris Balloon Dilation Catheter is intended to dilate strictures of the airway.

Source page: https://510kreport.com/device/K150951
Methodology: https://510kreport.com/methodology