510(k) · Cleared
ClearedPantera Pro
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 Oct 7, 2016 as substantially equivalent to P790017 (Medtronic, Ireland, 1980) and 2 other predicates after a 182-day review. Its family tree reaches back 2 generations to 1980. 3 later devices descend from it.
- Decided
- Oct 7, 2016
- Review
- 182 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to P790017 (1980). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backP790017 Usci Dilatation CatheterMedtronic, Ireland · 1980
- 1 generation backK103095 Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw BalloonMedtronic, Ireland · 2010
- This deviceK160985 Pantera ProBiotronik, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK163660 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 3 of 3 · See all- K163660Pantera LEOBiotronik, Inc. · 2017 · cites it directly2descendants
- K242969Pantera Pro; Pantera LEOBiotronik, Inc. · 2024 · cites it directly1descendant
- K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…Biotronik, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P790017 | Usci Dilatation Catheter | Medtronic, Ireland | 1980 | — |
| −1 | K103095 | Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon | Medtronic, Ireland | 2010 | — |
| 0 (this device) | K160985 | Pantera Pro | Biotronik, Inc. | 2016 | — |
| +1 | 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 |
|---|---|---|
| 2017 | 1 | 0 |
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P790017 | Usci Dilatation CatheterSummary page 4…er 2.0 – 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents. Predicate Device(s): Medtronic Sprinter Legend (P790017 /S096 & K103095) Boston Scientific Maverick2 (P860019 / S179).… | 1980 |
| * | K103095 | Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw BalloonSummary page 4…is also indicated for post-delivery expansion of balloon expandable stents. Predicate Device(s): Medtronic Sprinter Legend (P790017 /S096 & K103095) Boston Scientific Maverick2 (P860019 / S179).… | 2010 |
| * | P860019 | Scimed Ptca Dilatation CatheterSummary page 4…xpansion of balloon expandable stents. Predicate Device(s): Medtronic Sprinter Legend (P790017 /S096 & K103095) Boston Scientific Maverick2 (P860019 / S179). K16____… | 1986 |
What descends from it? (3)
2 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?
- The line of descent spans 36 years and passes through 2 companies; a new generation was cleared every 30.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K163660 (Biotronik, Inc., 2017) has gone furthest, with 2 descendants of its own.
- 12 other devices also cite its predicate P790017.
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. 2016, 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 Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 – 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160985 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160985: Pantera Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160985
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