510(k) · Cleared
ClearedPta Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Sep 25, 2014 as substantially equivalent to K053118 (Boston Scientific Corp, 2005) and 2 other predicates after a 143-day review. Its family tree reaches back 6 generations to 2000. 8 later devices descend from it.
- Decided
- Sep 25, 2014
- Review
- 143 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K001134 (2000). 8 ancestors in all. 8 later devices descend from it, 3 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 backK080982 Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation…Boston Scientific Corp · 2008
- 1 generation backK093720 Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL…Boston Scientific Corp · 2009
- This deviceK141150 Pta Balloon Dilatation CatheterBoston Scientific Corp · 2014
- Descendant · cites it directly · 3 of its ownK173894 Jade PTA Balloon Dilatation CatheterOrbusneich Medical Trading, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK202231 JADEOrbusNeich Medical (Shenzhen) Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK201794 JadeOrbusNeich Medical (Shenzhen) Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK181128 Paladin Carotid Post-dilation Balloon System with Integrated Embolic…Contego Medical, LLC · 2018
- Descendant · cites it directly · 1 of its ownK162350 Coyote Monorail Percutaneous Transluminal Angioplasty Balloon…Boston Scientific Corporation · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K173894Jade PTA Balloon Dilatation CatheterOrbusneich Medical Trading, Inc. · 2018 · cites it directly3descendants
- K202231JADEOrbusNeich Medical (Shenzhen) Co., Ltd. · 2020 · 2 generations on1descendant
- K201794JadeOrbusNeich Medical (Shenzhen) Co., Ltd. · 2020 · 2 generations on1descendant
- K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin…Contego Medical, LLC · 2018 · cites it directly1descendant
- K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter…Boston Scientific Corporation · 2016 · cites it directly1descendant
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 | K080982 | Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters | Boston Scientific Corp | 2008 | — |
| −1 | K093720 | Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL… | Boston Scientific Corp | 2009 | — |
| 0 (this device) | K141150 | Pta Balloon Dilatation Catheter | Boston Scientific Corp | 2014 | — |
| +1 | K173894 | Jade PTA Balloon Dilatation Catheter | Orbusneich Medical Trading, Inc. | 2018 | — |
| +2 | K202231 | JADE | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2020 | — |
| +2 | K201794 | Jade | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2020 | — |
| +1 | K181128 | Paladin Carotid Post-dilation Balloon System with Integrated Embolic… | Contego Medical, LLC | 2018 | — |
| +1 | K162350 | Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation… | Boston Scientific Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K053118 | Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-XxxxxxSummary page 4…heral, Transluminal Classification Class II, 21 CFR Part 870.1250 – Percutaneous Catheter Predicate Sterling™ Monorail™ PTA Balloon Dilatation Catheter, K053118, cleared Device(s) 16 December 2005 Sterling™ OTW PTA Balloon Dilatation Catheter, K132430, clear… | 2005 |
| * | K132430 | Sterling Over-the-Wire (Otw) Pta Balloon Dilatation CatheterSummary page 4…ng™ Monorail™ PTA Balloon Dilatation Catheter, K053118, cleared Device(s) 16 December 2005 Sterling™ OTW PTA Balloon Dilatation Catheter, K132430, cleared 17 October 2013 Sterling™ SL Monorail™ and OTW PTA Balloon Dilatation Catheter… | 2013 |
| * | K093720 | Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon…Summary page 4…atheter, K132430, cleared 17 October 2013 Sterling™ SL Monorail™ and OTW PTA Balloon Dilatation Catheters, K093720, cleared 23 December 2009 Device The Sterling Monorail Percutaneous Transluminal Angioplasty (PTA) Description… | 2009 |
What descends from it? (8)
3 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 14 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K173894 (Orbusneich Medical Trading, Inc., 2018) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K053118.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Sterling™ Monorail™ Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141150: 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/K141150
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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