# K110218: Inspira Air Balloon Dilation System

- Pathway: 510(k) (Special)
- Applicant: Acclarent, Inc.
- Decided: Mar 31, 2011 after 65 days
- Product code: KTI (Bronchoscope Accessory)
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 9 (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.
No later device cites it as a predicate yet.
0 of 7 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 1.
- K023337: Cre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310, M00550320, M00550330, M00550340, M00550350, Boston Scientific Corp (2002)

## Recalls of this device
- Apr 4, 2025 · Class II · Z-1724-2025: Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
- Jan 11, 2013 · Class II · Z-1863-2013: Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
- Jan 11, 2013 · Class II · Z-1864-2013: Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
- Jan 11, 2013 · Class II · Z-1862-2013: Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
- Jan 11, 2013 · Class II · Z-1866-2013: Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
- Jan 11, 2013 · Class II · Z-1861-2013: Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
- Jan 11, 2013 · Class II · Z-1860-2013: Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
- Jan 11, 2013 · Class II · Z-1865-2013: Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
- Jan 30, 2012 · Not classified · Z-1095-2012: Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially result in airway obstruction.

## Indications for use
The Airway Balloon Catheter is an instrument intended to dilate strictures of the airway tree.

Source page: https://510kreport.com/device/K110218
Methodology: https://510kreport.com/methodology