510(k) Report

510(k) · Cleared

Cleared

Mini Trek (TM) RX and Trek (TM) RX Coronary Dilatation Catheter Mini Trek (TM) Otw and Trek (TM) Otw Dilatation Catheter

K103110510(k) TraditionalCleared Jan 10, 201194-day reviewClass II21 CFR 870.5100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Abbott Vascular-Cardiac Therapies · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

Cleared on Jan 10, 2011 after a 94-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.

Decided
Jan 10, 2011
Review
94 days
Class
Class II
Product code
LOX
Recalls
None
Predicates
0

9 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2018: 2 descendants cleared2021: 1 descendant cleared2013: 1 descendant cleared2015: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared2016: 1 descendant cleared2010201520202025
  1. This deviceK103110 Mini Trek (TM) RX and Trek (TM) RX Coronary Dilatation Catheter Mini…Abbott Vascular-Cardiac Therapies · 2011
  2. Descendant · cites it directly · 5 of its ownK112735 Tamarin Blue Ptca RX Dilatation CatheterNatec Medical, Ltd. · 2012
  3. Descendant · cites it directly · 2 of its ownK180040 NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary…Abbott Vascular · 2018
  4. Descendant · 2 generations on · 2 of its ownK131169 Mozec - RX Ptca Balloon Dilatation CatheterMeril Life Sciences Private Limited · 2013
  5. Descendant · 3 generations on · 1 of its ownK160961 Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited · 2016
  6. Descendant · 2 generations on · 0 of its ownK252116 Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd. · 2026

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12015: 12016: 12018: 22021: 12022: 12026: 1
2012high 2 (2018) · low 0 (2014)2026

Most influential descendants

Showing 5 of 9 · See all
  • K112735Tamarin Blue Ptca RX Dilatation CatheterNatec Medical, Ltd. · 2012 · cites it directly5descendants
  • K180040NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter…Abbott Vascular · 2018 · cites it directly2descendants
  • K131169Mozec - RX Ptca Balloon Dilatation CatheterMeril Life Sciences Private Limited · 2013 · 2 generations on2descendants
  • K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited · 2016 · 3 generations on1descendant
  • K252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K103110Mini Trek (TM) RX and Trek (TM) RX Coronary Dilatation Catheter Mini Trek (TM)…Abbott Vascular-Cardiac Therapies2011—
+1K112735Tamarin Blue Ptca RX Dilatation CatheterNatec Medical, Ltd.2012—
+1K180040NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation…Abbott Vascular2018—
+2K131169Mozec - RX Ptca Balloon Dilatation CatheterMeril Life Sciences Private Limited2013—
+3K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited2016—
+2K252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201510
201610
201820
202110
202210
202610
FIG. 1 — Lineage of K103110, 2011–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K254022 FLASH Flex™ Aorto-Ostial Angioplasty Systemscore 12.3 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—VOYAGER® RX Coronary Dilatation Catheter
Named without a submission number
—
*—VOYAGER® NC Coronary Dilatation Catheter
Named without a submission number
—
*—VOYAGER® OTW Coronary Dilatation Catheter
Named without a submission number
—

What descends from it? (9)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112735Tamarin Blue Ptca RX Dilatation CatheterNatec Medical, Ltd.20125
K180040NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter…Abbott Vascular20182

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, K112735 (Natec Medical, Ltd., 2012) has gone furthest, with 5 descendants of its own.

How does its category compare?

All LOX devices

LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · LOX

4in 2024

2007: 192008: 222009: 282010: 322011: 92012: 102013: 62014: 62015: 42016: 92017: 62018: 72019: 12020: 12021: 62022: 52023: 42024: 42026 (partial year): 6
2007high 32 (2010) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LOX

241in 2024

2011: 103 days median2012: 120 days median2013: 123 days median2014: 166 days median2015: 119 days median2016: 116 days median2017: 113 days median2018: 80 days median2021: 167 days median2022: 121 days median2023: 138 days median2024: 241 days median2026 (partial year): 156 days median
2007high 241 (2024) · low 80 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LOX

4in 2019

2007: 12008: 802019: 4
2007high 80 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LOX

1,890in 2025

2007: 1,0532008: 1,0632009: 1,3532010: 1,3922011: 2,0902012: 2,0922013: 2,4362014: 2,3162015: 2,0602016: 2,5782017: 2,7532018: 2,2252019: 2,1022020: 1,9742021: 1,7382022: 1,8162023: 1,7202024: 1,8042025: 1,890
2007high 2,753 (2017) · low 1,053 (2007)2025

MAUDE reports naming product code LOX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200719—11,053
200822—801,063
200928—01,353
201032—01,392
2011910302,090
20121012002,092
2013612302,436
2014616602,316
2015411902,060
2016911602,578
2017611302,753
201878002,225
20191—42,102
20201—01,974
2021616701,738
2022512101,816
2023413801,720
2024424101,804
20250—01,890
202661560—

What is it indicated for?

The TREKTNI RX, MINI TREKTMl RX, TREKTNIOTW, and MINI TREKTM OTW 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 perforusion; b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segement elevation myocardial infarction; c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).

Indications for use as stated in the FDA summary.

More from Abbott Vascular-Cardiac Therapies

21 FDA decisions under this applicant name. See the company

  • P110043/S015Omnilink Elite Vascular Balloon-Expandable Stent SystemAbbott Vascular-Cardiac Therapies · 2026
  • P110043/S014Omnilink Elite Vascular Balloon-Expandable Stent SystemAbbott Vascular-Cardiac Therapies · 2024
  • P110043/S013Omnilink Elite™ Vascular Balloon-Exoandable Stent SystemAbbott Vascular-Cardiac Therapies · 2022
  • P110043/S012Omnilink Elite OTW Stent SystemAbbott Vascular-Cardiac Therapies · 2020
  • P110043/S011Omnilink Elite Vascular Balloon-Expandable Stent SystemAbbott Vascular-Cardiac Therapies · 2016

Recent decisions in LOX

The LOX category page

  • K261428NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic Ireland · 2026
  • K261759Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic Ireland · 2026
  • K252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd. · 2026
  • K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc. · 2026
  • K252295RyureiTerumo Corporation · 2026

https://510kreport.com/device/K103110 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103110: Mini Trek (TM) RX and Trek (TM) RX Coronary Dilatation Catheter Mini Trek (TM) Otw and Trek (TM) Otw 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/K103110

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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