510(k) · Cleared
ClearedNC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Vascular · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Aug 24, 2018 as substantially equivalent to K103153 (Abbott Vascular-Cardiac Therapies, 2010) and 6 other predicates after a 231-day review. Its family tree reaches back 1 generation to 2010. 2 of the 10 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Aug 24, 2018
- Review
- 231 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 1 generation to K103153 (2010). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly. 2 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK103153 Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary…Abbott Vascular-Cardiac Therapies · 2010 · Recalled (Class I)
- This deviceK180040 NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary…Abbott Vascular · 2018
- Descendant · cites it directly · 0 of its ownK252116 Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK220634 NC TREK NEO Coronary Dilatation CatheterAbbott Vascular · 2022
Class I recalls in this family
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 | K103153 | Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary Dilatation… | Abbott Vascular-Cardiac Therapies | 2010 | Class I |
| 0 (this device) | K180040 | NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation… | Abbott Vascular | 2018 | — |
| +1 | K252116 | Firefighter™ Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | 2026 | — |
| +1 | K220634 | NC TREK NEO Coronary Dilatation Catheter | Abbott Vascular | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 1 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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.
2 devices in this family have a Class I recall. 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? (7)
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 |
|---|---|---|---|
| * | K103153 | Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary Dilatation CatheterSummary page 5…) Catheter 9. DEVICE CLASSIFICATION PTCA Catheter, LOX, Class II NAME 10. PREDICATE DEVICE NAME NC TREK™ RX Coronary Dilatation Catheter K103153, K110134 NC TREK™ OTW Coronary Dilatation Catheter K113464 TREK™ RX Coronary Dilatation Catheter K10311… | 2010 |
| * | K110134 | NC Trek RX Coronary Dilatation CatheterSummary page 5…r 9. DEVICE CLASSIFICATION PTCA Catheter, LOX, Class II NAME 10. PREDICATE DEVICE NAME NC TREK™ RX Coronary Dilatation Catheter K103153, K110134 NC TREK™ OTW Coronary Dilatation Catheter K113464 TREK™ RX Coronary Dilatation Catheter K103110, K11067… | 2011 |
| * | K113464 | NC Trek Otw Coronary Dilatation CatheterSummary page 5…, Class II NAME 10. PREDICATE DEVICE NAME NC TREK™ RX Coronary Dilatation Catheter K103153, K110134 NC TREK™ OTW Coronary Dilatation Catheter K113464 TREK™ RX Coronary Dilatation Catheter K103110, K110671, K123279… | 2012 |
| * | K103110 | Mini Trek (TM) RX and Trek (TM) RX Coronary Dilatation Catheter Mini Trek (TM) Otw and…Summary page 5…oronary Dilatation Catheter K103153, K110134 NC TREK™ OTW Coronary Dilatation Catheter K113464 TREK™ RX Coronary Dilatation Catheter K103110, K110671, K123279 K103110, K110671, K121222, TREK™ OTW Coronary Dilatation… | 2011 |
| * | K110617 | Mini Trek RX 1.20 MM Coronary Dilatation Catheter, Mini Trek Otw 1.20 MM Coronary… Our reading of the summary gave K110671, FDA’s number for Winco Stretchair (Winco Mfg., LLC). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “TREK™ RX Coronary Dilatation Catheter”. | 2011 |
| * | K123279 | Mini Trek RX Coronary Dilatation Catheter (Including 1.20 MM Size), Mini Trek Otw…Summary page 5…Catheter K103153, K110134 NC TREK™ OTW Coronary Dilatation Catheter K113464 TREK™ RX Coronary Dilatation Catheter K103110, K110671, K123279 K103110, K110671, K121222, TREK™ OTW Coronary Dilatation Catheter… | 2013 |
| * | K121222 | Trek Otw Coronary Dilatation Catheter Mini Trek Otw Coronary Dilatation CatheterSummary page 5…r K113464 TREK™ RX Coronary Dilatation Catheter K103110, K110671, K123279 K103110, K110671, K121222, TREK™ OTW Coronary Dilatation Catheter K123279 MINI TREK™ RX Coronary Dilatation Catheter K103110, K1106… | 2012 |
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? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K110134NC Trek RX Coronary Dilatation CatheterAbbott Vascular-Cardiac Therapies · 2011 · Direct predicate · ◆ in the 2011 ancestors bar of FIG. 117 Class I recalls
- K103153Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary Dilatation CatheterAbbott Vascular-Cardiac Therapies · 2010 · Direct predicate · ◆ on the line of descent in FIG. 120 Class I recalls
What does this lineage say?
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 NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction; c) balloon dilatation of a stent after implantation (balloon models 2.0 mm – 5.0 mm only). The…
Read the full statement (431 words)
The NC TREK RX Coronary Dilatation Catheter is indicated for:
a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion;
b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction;
c) balloon dilatation of a stent after implantation (balloon models 2.0 mm – 5.0 mm only).
The NC TREK OTW Coronary Dilatation Catheter is indicated for:
a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion;
b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction;
c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm – 5.00 mm only)
The TREK RX Coronary Dilatation Catheters are indicated for:
a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion;
b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction;
c) Balloon dilatation of a stent after implantation.
The TREK OTW and MINI TREK OTW Coronary Dilatation Catheter is indicated for:
a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion;
b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction;
c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm –5.00 mm only).
The MINI TREK RX Coronary Dilatation Catheters are indicated for:
a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion;
b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction;
c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm only);
d) Balloon dilatation of de novo chronic total coronary occlusions (CTO).
The MINI TREK II OTW Coronary Dilatation Catheter is indicated for:
a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion;
b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction (MI);
c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm only);
d) Balloon dilatation of de novo chronic total coronary occlusions (CTO).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180040: NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary 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/K180040
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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