510(k) · Cleared
ClearedCre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310, M00550320, M00550330, M00550340, M00550350
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · KTI Bronchoscope Accessory
Cleared on Nov 18, 2002 after a 42-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.
- Decided
- Nov 18, 2002
- Review
- 42 days
- Class
- Class II
- Product code
- KTI
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 6 citing it directly.
- This deviceK023337 Cre Pulmonary Balloon Dilatation Catheter, Models K00550300…Boston Scientific Corp · 2002
- Descendant · cites it directly · 5 of its ownK131234 Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon)Broncus Medical, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK090660 Airway Balloon Catheter Inflation DeviceAcclarent, Inc. · 2009 · Recalled
- Descendant · cites it directly · 2 of its ownK170759 CRE Pulmonary Balloon Dilatation CatheterBoston Scientific Corporation · 2017
- Descendant · 2 generations on · 2 of its ownK142934 CrossCountry Transbronchial Access Tool straight, CrossCountry…Covidien · 2015
- Descendant · cites it directly · 1 of its ownK161392 Elation Pulmonary Balloon DilationMerit Medical Systems, Inc. · 2016
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K131234Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon)Broncus Medical, Inc. · 2013 · cites it directly5descendants
- K090660Airway Balloon Catheter Inflation DeviceAcclarent, Inc. · 2009 · cites it directly4descendants
- K170759CRE Pulmonary Balloon Dilatation CatheterBoston Scientific Corporation · 2017 · cites it directly2descendants
- K142934CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access…Covidien · 2015 · 2 generations on2descendants
- K161392Elation Pulmonary Balloon DilationMerit Medical Systems, Inc. · 2016 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023337 | Cre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310… | Boston Scientific Corp | 2002 | — |
| +1 | K131234 | Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon) | Broncus Medical, Inc. | 2013 | — |
| +1 | K090660 | Airway Balloon Catheter Inflation Device | Acclarent, Inc. | 2009 | 7 |
| +1 | K170759 | CRE Pulmonary Balloon Dilatation Catheter | Boston Scientific Corporation | 2017 | — |
| +2 | K142934 | CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial… | Covidien | 2015 | — |
| +1 | K161392 | Elation Pulmonary Balloon Dilation | Merit Medical Systems, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | CRE Balloon Dilatation Catheter Named without a submission number |
What descends from it? (16)
See all 166 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131234 | Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon) | 2013 | 5 |
| K090660 | Airway Balloon Catheter Inflation Device | 2009 | 4 |
| K170759 | CRE Pulmonary Balloon Dilatation Catheter | 2017 | 2 |
| K161392 | Elation Pulmonary Balloon Dilation | 2016 | 1 |
| K150951 | aeris Balloon Dialation Catheter | 2015 | 1 |
| K110218 | Inspira Air Balloon Dilation System | 2011 | 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?
- Of its descendants, K131234 (Broncus Medical, Inc., 2013) has gone furthest, with 5 descendants of its own.
How does its category compare?
All KTI devicesKTI Bronchoscope Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years.
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/K023337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023337: Cre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310, M00550320, M00550330, M00550340, M00550350.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023337
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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