510(k) · Cleared
ClearedCRE Pulmonary Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · KTI Bronchoscope Accessory
Cleared on Jun 23, 2017 as substantially equivalent to K023337 (Boston Scientific Corp, 2002) after a 102-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Jun 23, 2017
- Review
- 102 days
- Class
- Class II
- Product code
- KTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023337 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK023337 Cre Pulmonary Balloon Dilatation Catheter, Models K00550300…Boston Scientific Corp · 2002
- This deviceK170759 CRE Pulmonary Balloon Dilatation CatheterBoston Scientific Corporation · 2017
- Descendant · cites it directly · 0 of its ownK222187 Multistage Balloon Dilatation CatheterDongguan TT Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK211894 TrachealatorDisa Medinotec · 2021
Most influential descendants
Showing 2 of 2 · See allView 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) | K170759 | CRE Pulmonary Balloon Dilatation Catheter | Boston Scientific Corporation | 2017 | — |
| +1 | K222187 | Multistage Balloon Dilatation Catheter | Dongguan TT Medical, Inc. | 2023 | — |
| +1 | K211894 | Trachealator | Disa Medinotec | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (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…Balloon Dilatation Catheter Common Name: Balloon Dilatation Catheter Manufacturer: Boston Scientific Corporation Clearance Number: K023337 Classification Name: Bronchoscope (flexible and rigid) and accessories Regulation Number: 21 CFR 874.4680 Pr… | 2002 |
| † | K161392 | Elation Pulmonary Balloon Dilation | 2016 |
What descends from it? (2)
2 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)
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. 2017, 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 CRE Pulmonary Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170759: CRE Pulmonary Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170759
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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