510(k) · Cleared
Recalled · Class II · 2025Inspira Air Balloon Dilation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acclarent, Inc. · KTI Bronchoscope Accessory
Cleared on Mar 31, 2011 as substantially equivalent to K090660 (Acclarent, Inc., 2009) and 1 other predicate after a 65-day review. Its family tree reaches back 4 generations to 2005. It has been recalled 9 times.
- Decided
- Mar 31, 2011
- Review
- 65 days
- Class
- Class II
- Product code
- KTI
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 4 generations to K043527 (2005). 6 ancestors in all, the oldest K023337 (2002). No later device cites it as a predicate yet.
- Root · 4 generations backK043527 Relieva Sinus Balloon Dilation CatheterExploramed Nc1, Inc. · 2005
- 3 generations backK061903 Relieva Sinus Balloon CatheterAcclarent, Inc. · 2006
- 2 generations backK073041 Relieva and Relieva Acella Sinus Balloon CatheterAcclarent, Inc. · 2008
- 1 generation backK090660 Airway Balloon Catheter Inflation DeviceAcclarent, Inc. · 2009 · Recalled
- This deviceK110218 Inspira Air Balloon Dilation SystemAcclarent, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K043527 | Relieva Sinus Balloon Dilation Catheter | Exploramed Nc1, Inc. | 2005 | — |
| −3 | K061903 | Relieva Sinus Balloon Catheter | Acclarent, Inc. | 2006 | — |
| −2 | K073041 | Relieva and Relieva Acella Sinus Balloon Catheter | Acclarent, Inc. | 2008 | — |
| −1 | K090660 | Airway Balloon Catheter Inflation Device | Acclarent, Inc. | 2009 | 7 |
| 0 (this device) | K110218 | Inspira Air Balloon Dilation System | Acclarent, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KTI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KTI device
- #1 K261274 EchoTip Ultra® Endobronchial HD Ultrasound…score 15.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090660 | Airway Balloon Catheter Inflation DeviceSummary page 1…me: Bronchoscope (flexible or rigid) and accessories Product Code: KTI Predicate Devices: Acciarent Airway Balloon Catheter and Accessories (K090660) Boston Scientific CRE Pulmonary Balloon Dilation Catheter (K(02333 7) De… | 2009 |
| * | K023337 | Cre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310, M00550320… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 4, 2025 | Class II | Z-1724-2025 | Under Investigation by firm | Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton. |
| Jan 11, 2013 | Class II | Z-1863-2013 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Component design/selection | Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially result in airway obstruction. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 3 other devices also cite its predicate K090660.
How does its category compare?
All KTI devicesKTI Bronchoscope Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KTI
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTI
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTI
198in 2025
MAUDE reports naming product code KTI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 11 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 17 |
| 2012 | 0 | — | 1 | 12 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 3 | 140 | 0 | 7 |
| 2017 | 3 | 115 | 0 | 9 |
| 2018 | 1 | — | 1 | 14 |
| 2019 | 1 | — | 0 | 27 |
| 2020 | 1 | — | 0 | 37 |
| 2021 | 1 | — | 0 | 47 |
| 2022 | 3 | 137 | 0 | 131 |
| 2023 | 4 | 168 | 0 | 130 |
| 2024 | 0 | — | 0 | 149 |
| 2025 | 5 | 61 | 0 | 198 |
| 2026 | 3 | 98 | 0 | — |
What is it indicated for?
The Airway Balloon Catheter is an instrument intended to dilate strictures of the airway tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110218: Inspira Air Balloon Dilation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110218
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026