# K231818: METIC™- Airway Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: M/S Meril Life Sciences Pvt., Ltd.
- Decided: Nov 15, 2023 after 147 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: 5 generations back to K043527 (2005). 7 ancestors in all.
No later device cites it as a predicate yet.
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 5.
- K150951: aeris Balloon Dialation Catheter, Bryan Medical, Inc. (2015) Summary page 5.

## Indications for use
METIC™ – Airway Balloon Catheter is intended to dilate strictures of the airway.

Source page: https://510kreport.com/device/K231818
Methodology: https://510kreport.com/methodology