510(k) · Cleared
ClearedMultistage Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dongguan TT Medical, Inc. · KTI Bronchoscope Accessory
Cleared on Mar 1, 2023 as substantially equivalent to K170759 (Boston Scientific Corporation, 2017) after a 222-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Mar 1, 2023
- Review
- 222 days
- Class
- Class II
- Product code
- KTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K023337 (2002). No later device cites it as a predicate yet.
- Root · 2 generations backK023337 Cre Pulmonary Balloon Dilatation Catheter, Models K00550300…Boston Scientific Corp · 2002
- 1 generation backK170759 CRE Pulmonary Balloon Dilatation CatheterBoston Scientific Corporation · 2017
- This deviceK222187 Multistage Balloon Dilatation CatheterDongguan TT Medical, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023337 | Cre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310… | Boston Scientific Corp | 2002 | — |
| −1 | K170759 | CRE Pulmonary Balloon Dilatation Catheter | Boston Scientific Corporation | 2017 | — |
| 0 (this device) | K222187 | Multistage Balloon Dilatation Catheter | Dongguan TT Medical, Inc. | 2023 | — |
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 |
|---|---|---|---|
| * | K170759 | CRE Pulmonary Balloon Dilatation CatheterSummary page 4…Applicant Device name 510(k) Number Product code Boston Scientific CRE Pulmonary Balloon Dilatation K170759 KTI Corp Catheter 6. Device Description The MultiStage Balloon Dilatation Catheter is intended… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 14.6 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K170759.
How does its category compare?
All KTI devicesKTI Bronchoscope Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
MultiStage balloon dilatation catheter is intended to be used to dilate strictures located in the airway tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222187 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222187: Multistage Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222187
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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