# K090660: Airway Balloon Catheter Inflation Device

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Jun 12, 2009 after 92 days
- Product code: KTI (Bronchoscope Accessory)
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K043527 (2005). 5 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 10 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 1.
- K073041: Relieva and Relieva Acella Sinus Balloon Catheter, Acclarent, Inc. (2008) Summary page 1.
- K052198: Relieva Sinus Balloon Inflation Device, Acclarent, Inc. (2005) Summary page 1.
- (no number) Boston Scientific Alliance II Inflation System: named in the summary without a submission number

## Most influential descendants
- K150951: aeris Balloon Dialation Catheter (2015), 1 descendant of its own
- K231818: METIC™- Airway Balloon Catheter (2023), 0 descendants of its own
- K153484: Dillard Airway Dilatation System (2016), 0 descendants of its own
- K110218: Inspira Air Balloon Dilation System (2011), 0 descendants of its own

## Recalls of this device
- 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.

## Indications for use
The Airway Balloon Catheter is an instrument intended to dilate strictures of the airway tree. The Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used in sinus procedures and dilation of the airway tree.

Source page: https://510kreport.com/device/K090660
Methodology: https://510kreport.com/methodology