510(k) · Cleared
Recalled · Class II · 2023aeris Balloon Dialation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bryan Medical, Inc. · KTI Bronchoscope Accessory
Cleared on Jun 25, 2015 as substantially equivalent to K090660 (Acclarent, Inc., 2009) and 1 other predicate after a 77-day review. Its family tree reaches back 4 generations to 2005. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 25, 2015
- Review
- 77 days
- Class
- Class II
- Product code
- KTI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K043527 (2005). 6 ancestors in all, the oldest K023337 (2002). 1 later device descends from it, 1 citing it directly.
- 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 deviceK150951 aeris Balloon Dialation CatheterBryan Medical, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK231818 METIC™- Airway Balloon CatheterM/S Meril Life Sciences Pvt., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K231818METIC™- Airway Balloon CatheterM/S Meril Life Sciences Pvt., Ltd. · 2023 · cites it directly0descendants
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) | K150951 | aeris Balloon Dialation Catheter | Bryan Medical, Inc. | 2015 | — |
| +1 | K231818 | METIC™- Airway Balloon Catheter | M/S Meril Life Sciences Pvt., Ltd. | 2023 | — |
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 |
|---|---|---|
| 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? (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 4….4680 Product Code: KTI Review Panel: Ear, Nose, & Throat Predicate Device: Acclarent Inspira AIR Balloon Dilation System (K090660) Boston Scientific CRE Pulmonary Balloon Dilation Catheter (K… | 2009 |
| * | K023337 | Cre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310, M00550320…Summary page 4…pira AIR Balloon Dilation System (K090660) Boston Scientific CRE Pulmonary Balloon Dilation Catheter (K023337) Bryan Medical, aeris Balloon Dilation Catheter Page F.1 of F.11… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231818 | METIC™- Airway Balloon Catheter | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2023 | Class II | Z-2148-2023 | Error in labeling | Devices were mislabeled. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K231818 (M/S Meril Life Sciences Pvt., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 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. 2015, 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 aeris Balloon Dilation Catheter is intended to dilate strictures of the airway.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150951 · printed Nov 3, 2026
Cite this page
510(k) Report. “K150951: aeris Balloon Dialation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150951
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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