510(k) · Cleared
ClearedOTW Takeru PTCA Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KANEKA Corporation · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Mar 19, 2018 as substantially equivalent to K163372 (KANEKA Corporation, 2017) and 1 other predicate after a 235-day review. Its family tree reaches back 3 generations to 1980.
- Decided
- Mar 19, 2018
- Review
- 235 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P790017 (1980). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backP790017 Usci Dilatation CatheterMedtronic, Ireland · 1980
- 2 generations backK143480 Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic, Inc. · 2015 · Recalled
- 1 generation backK163372 RX Takeru Balloon Dilatation CatheterKANEKA Corporation · 2017
- This deviceK172264 OTW Takeru PTCA Balloon Dilatation CatheterKANEKA Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P790017 | Usci Dilatation Catheter | Medtronic, Ireland | 1980 | — |
| −2 | K143480 | Euphora Rapid Exchange Balloon Dilatation Catheter | Medtronic, Inc. | 2015 | 3 |
| −1 | K163372 | RX Takeru Balloon Dilatation Catheter | KANEKA Corporation | 2017 | — |
| 0 (this device) | K172264 | OTW Takeru PTCA Balloon Dilatation Catheter | KANEKA Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 LOX? 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 LOX device
- #1 K254022 FLASH Flex™ Aorto-Ostial Angioplasty Systemscore 12.3 · 5 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 |
|---|---|---|---|
| * | K163372 | RX Takeru Balloon Dilatation CatheterSummary page 5…Classification Panel Cardiovascular (74) Predicate Devices: • Primary predicate device: RX Takeru PTCA Balloon Dilatation Catheter or “RX Takeru” [K163372 (Kaneka Corporation)] • ApexTM Over-The-Wire PTCA Dilatation Catheter or “Apex Over-The-Wire” [P860019/S208 (Boston Sc… | 2017 |
| * | P860019/ | Apex Monorail and Over-the-Wire Ptca Dilatation CathetersSummary page 5…PTCA Balloon Dilatation Catheter or “RX Takeru” [K163372 (Kaneka Corporation)] • ApexTM Over-The-Wire PTCA Dilatation Catheter or “Apex Over-The-Wire” [P860019/S208 (Boston Scientific Corporation)] Reference Device: • Crosstella OTW PTA Balloon Dilatation Catheter or “Crosstella OTW” [K1… | 2008 |
| † | K160004 | Crosstella OTW | 2016 |
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 38 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All LOX devicesLOX Catheters, Transluminal Coronary Angioplasty, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LOX
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LOX
241in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOX
4in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOX
1,890in 2025
MAUDE reports naming product code LOX, 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 | 19 | — | 1 | 1,053 |
| 2008 | 22 | — | 80 | 1,063 |
| 2009 | 28 | — | 0 | 1,353 |
| 2010 | 32 | — | 0 | 1,392 |
| 2011 | 9 | 103 | 0 | 2,090 |
| 2012 | 10 | 120 | 0 | 2,092 |
| 2013 | 6 | 123 | 0 | 2,436 |
| 2014 | 6 | 166 | 0 | 2,316 |
| 2015 | 4 | 119 | 0 | 2,060 |
| 2016 | 9 | 116 | 0 | 2,578 |
| 2017 | 6 | 113 | 0 | 2,753 |
| 2018 | 7 | 80 | 0 | 2,225 |
| 2019 | 1 | — | 4 | 2,102 |
| 2020 | 1 | — | 0 | 1,974 |
| 2021 | 6 | 167 | 0 | 1,738 |
| 2022 | 5 | 121 | 0 | 1,816 |
| 2023 | 4 | 138 | 0 | 1,720 |
| 2024 | 4 | 241 | 0 | 1,804 |
| 2025 | 0 | — | 0 | 1,890 |
| 2026 | 6 | 156 | 0 | — |
What is it indicated for?
The OTW Takeru PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion in the coronary artery or bypass graft stenosis for the purpose of myocardial perfusion.
This product (balloon models 2.0 - 5.0 mm) is also indicated for the post-delivery expansion of balloon expandable stents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172264: OTW Takeru PTCA 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/K172264
Report an extraction error
Are you the manufacturer?
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