510(k) · Cleared
ClearedPantera LEO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Jan 26, 2017 as substantially equivalent to K160985 (Biotronik, Inc., 2016) after a 30-day review. Its family tree reaches back 3 generations to 1980. 2 later devices descend from it.
- Decided
- Jan 26, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P790017 (1980). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backP790017 Usci Dilatation CatheterMedtronic, Ireland · 1980
- 2 generations backK103095 Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw BalloonMedtronic, Ireland · 2010
- 1 generation backK160985 Pantera ProBiotronik, Inc. · 2016
- This deviceK163660 Pantera LEOBiotronik, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK242969 Pantera Pro; Pantera LEOBiotronik, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK250706 Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral…Biotronik, Inc. · 2025
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 |
|---|---|---|---|---|---|
| −3 | P790017 | Usci Dilatation Catheter | Medtronic, Ireland | 1980 | — |
| −2 | K103095 | Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon | Medtronic, Ireland | 2010 | — |
| −1 | K160985 | Pantera Pro | Biotronik, Inc. | 2016 | — |
| 0 (this device) | K163660 | Pantera LEO | Biotronik, Inc. | 2017 | — |
| +1 | K242969 | Pantera Pro; Pantera LEO | Biotronik, Inc. | 2024 | — |
| +2 | K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation… | Biotronik, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K160985 | Pantera ProSummary page 4…870.5100 Classification Name: Catheter, transluminal coronary angioplasty, percutaneous Product Code: LOX Predicate Device(s): BIOTRONIK Pantera Pro (K160985, cleared October 7, 2016) Device Description: The Pantera LEO PTCA catheter is a sterile, single-use, intravascular balloon… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242969 | Pantera Pro; Pantera LEO | 2024 | 1 |
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 37 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K242969 (Biotronik, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K160985.
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. 2017, 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 Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163660: Pantera LEO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163660
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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