510(k) · Cleared
ClearedInfinity Angioplasty Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infinity Angioplasty Balloon Company, LLC · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on May 20, 2020 as substantially equivalent to K141112 (Boston Scientific, 2014) after a 260-day review. Its family tree reaches back 6 generations to 2000. 3 later devices descend from it.
- Decided
- May 20, 2020
- Review
- 260 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001134 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 5 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 4 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 3 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 2 generations backK132430 Sterling Over-the-Wire (Otw) Pta Balloon Dilatation CatheterBoston Scientific Corp · 2013
- 1 generation backK141112 Sterling Over-the Wire Pta Balloon Dilatation CatheterBoston Scientific · 2014
- This deviceK192399 Infinity Angioplasty Balloon CatheterInfinity Angioplasty Balloon Company, LLC · 2020
- Descendant · cites it directly · 2 of its ownK214038 Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK241711 Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc. · 2024
- Descendant · 3 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- K214038Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc. · 2022 · cites it directly2descendants
- K241711Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc. · 2024 · 2 generations on1descendant
- K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…Biotronik, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −5 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −4 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −3 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −2 | K132430 | Sterling Over-the-Wire (Otw) Pta Balloon Dilatation Catheter | Boston Scientific Corp | 2013 | — |
| −1 | K141112 | Sterling Over-the Wire Pta Balloon Dilatation Catheter | Boston Scientific | 2014 | — |
| 0 (this device) | K192399 | Infinity Angioplasty Balloon Catheter | Infinity Angioplasty Balloon Company, LLC | 2020 | — |
| +1 | K214038 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | 2022 | — |
| +2 | K241711 | Oscar Peripheral Multifunctional Catheter system | Biotronik, Inc. | 2024 | — |
| +3 | K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation… | Biotronik, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 LIT? 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 LIT device
- #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 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 |
|---|---|---|---|
| * | K141112 | Sterling Over-the Wire Pta Balloon Dilatation CatheterSummary page 4…lent to the following device: • Boston Scientific Corporation Sterling Over-the-Wire PTA Balloon Catheter (K141112) Device Description: The INFINITY Angioplasty Balloon Catheter is a intravascular angioplasty balloon… | 2014 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K214038 | Oscar Peripheral Multifunctional Catheter system | 2022 | 2 |
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 20 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K214038 (Biotronik, Inc., 2022) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LIT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LIT
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIT
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LIT
2,073in 2025
MAUDE reports naming product code LIT, 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 | 6 | 64 | 0 | 577 |
| 2008 | 8 | 53 | 0 | 513 |
| 2009 | 7 | 29 | 2 | 623 |
| 2010 | 13 | 78 | 1 | 809 |
| 2011 | 10 | 82 | 0 | 857 |
| 2012 | 19 | 29 | 0 | 1,277 |
| 2013 | 14 | 79 | 2 (2) | 1,242 |
| 2014 | 12 | 90 | 3 | 1,178 |
| 2015 | 19 | 112 | 0 | 1,279 |
| 2016 | 11 | 116 | 1 | 1,529 |
| 2017 | 9 | 57 | 0 | 2,081 |
| 2018 | 6 | 118 | 2 | 2,188 |
| 2019 | 4 | 40 | 3 | 2,405 |
| 2020 | 9 | 125 | 0 | 2,443 |
| 2021 | 4 | 61 | 1 | 2,492 |
| 2022 | 8 | 122 | 0 | 2,155 |
| 2023 | 6 | 167 | 0 | 1,807 |
| 2024 | 6 | 43 | 2 | 1,913 |
| 2025 | 3 | 90 | 1 | 2,073 |
| 2026 | 4 | 205 | 0 | — |
What is it indicated for?
The INFINITY Angioplasty Balloon Catheter™ is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary or cerebrovascular arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192399 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192399: Infinity Angioplasty Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192399
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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