510(k) · Cleared
ClearedSprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Ireland · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Oct 22, 2010 as substantially equivalent to P790017 (Medtronic, Ireland, 1980) after a 14-day review. Its family tree reaches back 1 generation to 1980. 13 later devices descend from it.
- Decided
- Oct 22, 2010
- Review
- 14 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P790017 (1980). 13 later devices descend from it, 4 citing it directly.
- Root · 1 generation backP790017 Usci Dilatation CatheterMedtronic, Ireland · 1980
- This deviceK103095 Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw BalloonMedtronic, Ireland · 2010
- Descendant · cites it directly · 5 of its ownK112735 Tamarin Blue Ptca RX Dilatation CatheterNatec Medical, Ltd. · 2012
- Descendant · cites it directly · 3 of its ownK160985 Pantera ProBiotronik, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK163660 Pantera LEOBiotronik, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK131169 Mozec - RX Ptca Balloon Dilatation CatheterMeril Life Sciences Private Limited · 2013
- Descendant · 2 generations on · 1 of its ownK242969 Pantera Pro; Pantera LEOBiotronik, Inc. · 2024
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K112735Tamarin Blue Ptca RX Dilatation CatheterNatec Medical, Ltd. · 2012 · cites it directly5descendants
- K160985Pantera ProBiotronik, Inc. · 2016 · cites it directly3descendants
- K163660Pantera LEOBiotronik, Inc. · 2017 · 2 generations on2descendants
- K131169Mozec - RX Ptca Balloon Dilatation CatheterMeril Life Sciences Private Limited · 2013 · 2 generations on2descendants
- K242969Pantera Pro; Pantera LEOBiotronik, Inc. · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P790017 | Usci Dilatation Catheter | Medtronic, Ireland | 1980 | — |
| 0 (this device) | K103095 | Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon | Medtronic, Ireland | 2010 | — |
| +1 | K112735 | Tamarin Blue Ptca RX Dilatation Catheter | Natec Medical, Ltd. | 2012 | — |
| +1 | K160985 | Pantera Pro | Biotronik, Inc. | 2016 | — |
| +2 | K163660 | Pantera LEO | Biotronik, Inc. | 2017 | — |
| +2 | K131169 | Mozec - RX Ptca Balloon Dilatation Catheter | Meril Life Sciences Private Limited | 2013 | — |
| +2 | K242969 | Pantera Pro; Pantera LEO | Biotronik, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | P790017 | Usci Dilatation CatheterSummary page 2…operation to the approved predicates Sprinter Legend RX device (1.5-4.0mm) (P790017/S096) and Sprinter OTW Balloon Dilatation Catheter (P790017/SO81). The indications… | 1980 |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2010, 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 Sprinter Legend RX and OTW 1.25mm Balloon Dilatation Catheter is indicated as a pre-dilatation catheter for enlarging coronary luminal diameters during PCI procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103095: Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103095
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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