510(k) · Cleared
ClearedElation Pulmonary Balloon Dilation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · KTI Bronchoscope Accessory
Cleared on Sep 1, 2016 as substantially equivalent to K023337 (Boston Scientific Corp, 2002) after a 105-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.
- Decided
- Sep 1, 2016
- Review
- 105 days
- Class
- Class II
- Product code
- KTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023337 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK023337 Cre Pulmonary Balloon Dilatation Catheter, Models K00550300…Boston Scientific Corp · 2002
- This deviceK161392 Elation Pulmonary Balloon DilationMerit Medical Systems, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK213434 Elation Pulmonary Balloon Dilation CatheterMerit Medical Systems, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K213434Elation Pulmonary Balloon Dilation CatheterMerit Medical Systems, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023337 | Cre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310… | Boston Scientific Corp | 2002 | — |
| 0 (this device) | K161392 | Elation Pulmonary Balloon Dilation | Merit Medical Systems, Inc. | 2016 | — |
| +1 | K213434 | Elation Pulmonary Balloon Dilation Catheter | Merit Medical Systems, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (1)
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 4…Classification Name: Bronchoscope (flexible and rigid) and Predicate Device accessories Premarket Notification: K023337 Manufacturer: Boston Scientific Corporation Class II Classification… | 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 |
|---|---|---|---|
| K213434 | Elation Pulmonary Balloon Dilation Catheter | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KTI devicesKTI Bronchoscope Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Elation™ Pulmonary Balloon Dilation Catheter is intended to be used to endoscopically dilate strictures of the trachea and bronchi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161392: Elation Pulmonary Balloon Dilation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161392
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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