510(k) · Cleared
ClearedAthletis PTA Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Sep 15, 2020 as substantially equivalent to K103751 (Boston Scientific, 2011) after a 137-day review. Its family tree reaches back 6 generations to 2000. 1 later device descends from it.
- Decided
- Sep 15, 2020
- Review
- 137 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001134 (2000). 11 ancestors in all, the oldest K993305 (2000). 1 later device descends 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 backK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
- 1 generation backK103751 Mustang Balloon Dilatation CathetersBoston Scientific · 2011
- This deviceK201170 Athletis PTA Balloon Dilatation CatheterBoston Scientific Corporation · 2020
- Descendant · cites it directly · 0 of its ownK260416 ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd. · 2026 · cites it directly0descendants
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 | K072283 | Dorado Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2007 | 15 |
| −1 | K103751 | Mustang Balloon Dilatation Catheters | Boston Scientific | 2011 | — |
| 0 (this device) | K201170 | Athletis PTA Balloon Dilatation Catheter | Boston Scientific Corporation | 2020 | — |
| +1 | K260416 | ZYLOX Hippo PTA Balloon Dilatation Catheter | Zylox Medtech Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K103751 | Mustang Balloon Dilatation CathetersSummary page 4…Dilatation Catheter Product Code LIT Classification Class II, 21 CFR Part 870.1250 Predicate Device Mustang Balloon Dilatation Catheter (K103751), cleared 22 March 2011 Reference Devices Gladiator PTA Balloon Dilatation Catheter (K113681), cleared 11 January… | 2011 |
| † | K113681 | Gladiator Pta Balloon Dilation Catheter | 2012 |
| † | K083657 | Conquest Pta Balloon Dilatation Catheter | 2008 |
| † | K120660 | Conquest 40 Pta Dilatation Catheter | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260416 | ZYLOX Hippo PTA Balloon Dilatation Catheter | 2026 | 0 |
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 5 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K260416 (Zylox Medtech Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K103751.
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 Athletis™ PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature including upper extremity, renal, iliac, and infrainguinal vessels and the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Athletis™ PTA Balloon Dilatation Catheter is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201170: Athletis PTA Balloon 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/K201170
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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