510(k) · Cleared
Recalled · Class II · 2013Airway Balloon Catheter Inflation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acclarent, Inc. · KTI Bronchoscope Accessory
Cleared on Jun 12, 2009 as substantially equivalent to K023337 (Boston Scientific Corp, 2002) and 2 other predicates after a 92-day review. Its family tree reaches back 3 generations to 2005. 4 later devices descend from it. It has been recalled 7 times.
- Decided
- Jun 12, 2009
- Review
- 92 days
- Class
- Class II
- Product code
- KTI
- Recalls
- 7
- Predicates
- 3
Its longest line of descent runs back 3 generations to K043527 (2005). 5 ancestors in all, the oldest K023337 (2002). 4 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK043527 Relieva Sinus Balloon Dilation CatheterExploramed Nc1, Inc. · 2005
- 2 generations backK061903 Relieva Sinus Balloon CatheterAcclarent, Inc. · 2006
- 1 generation backK073041 Relieva and Relieva Acella Sinus Balloon CatheterAcclarent, Inc. · 2008
- This deviceK090660 Airway Balloon Catheter Inflation DeviceAcclarent, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK150951 aeris Balloon Dialation CatheterBryan Medical, Inc. · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK231818 METIC™- Airway Balloon CatheterM/S Meril Life Sciences Pvt., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK153484 Dillard Airway Dilatation SystemIntuit Medical Products, LLC · 2016
- Descendant · cites it directly · 0 of its ownK110218 Inspira Air Balloon Dilation SystemAcclarent, Inc. · 2011 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K150951aeris Balloon Dialation CatheterBryan Medical, Inc. · 2015 · cites it directly1descendant
- K231818METIC™- Airway Balloon CatheterM/S Meril Life Sciences Pvt., Ltd. · 2023 · cites it directly0descendants
- K153484Dillard Airway Dilatation SystemIntuit Medical Products, LLC · 2016 · cites it directly0descendants
- K110218Inspira Air Balloon Dilation SystemAcclarent, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K043527 | Relieva Sinus Balloon Dilation Catheter | Exploramed Nc1, Inc. | 2005 | — |
| −2 | K061903 | Relieva Sinus Balloon Catheter | Acclarent, Inc. | 2006 | — |
| −1 | K073041 | Relieva and Relieva Acella Sinus Balloon Catheter | Acclarent, Inc. | 2008 | — |
| 0 (this device) | K090660 | Airway Balloon Catheter Inflation Device | Acclarent, Inc. | 2009 | — |
| +1 | K150951 | aeris Balloon Dialation Catheter | Bryan Medical, Inc. | 2015 | 1 |
| +1 | K231818 | METIC™- Airway Balloon Catheter | M/S Meril Life Sciences Pvt., Ltd. | 2023 | — |
| +1 | K153484 | Dillard Airway Dilatation System | Intuit Medical Products, LLC | 2016 | — |
| +1 | K110218 | Inspira Air Balloon Dilation System | Acclarent, Inc. | 2011 | 9 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K023337 | Cre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310, M00550320…Summary page 1…KTI LRC Predicate Devices: Boston Scientific CRE Pulmonary Balloon Dilation Catheter (K023337) Acciarent Relieva Sinus Balloon Catheter (K073 041) Acclarent Reliev… | 2002 |
| * | K073041 | Relieva and Relieva Acella Sinus Balloon CatheterSummary page 1…Boston Scientific CRE Pulmonary Balloon Dilation Catheter (K023337) Acciarent Relieva Sinus Balloon Catheter (K073 041) Acclarent Relieva Sinus Inflation Device (K052 198) Boston Scientifi… | 2008 |
| * | K052198 | Relieva Sinus Balloon Inflation DeviceSummary page 1…(K023337) Acciarent Relieva Sinus Balloon Catheter (K073 041) Acclarent Relieva Sinus Inflation Device (K052 198) Boston Scientific Alliance II Inflation System (K Number Unknown) D… | 2005 |
| * | — | Boston Scientific Alliance II Inflation System Named without a submission number |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
The 5 latest of 7 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 4 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K150951 (Bryan Medical, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K023337.
How does its category compare?
All KTI devicesKTI Bronchoscope Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090660 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090660: Airway Balloon Catheter Inflation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090660
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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