510(k) · Cleared
ClearedSterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031406020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031408020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031410020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031412020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031415020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H749390314
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 Jul 10, 2024 as substantially equivalent to K162350 (Boston Scientific Corporation, 2016) after a 29-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Jul 10, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K001134 (2000). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 7 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 6 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 5 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 4 generations backK080982 Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation…Boston Scientific Corp · 2008
- 3 generations backK093636 Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation…Boston Scientific Corp · 2009
- 2 generations backK111295 .014 Monorail and Otw Pta Balloon Dilatation CathetersBoston Scientific Corporation · 2011 · Recalled
- 1 generation backK162350 Coyote Monorail Percutaneous Transluminal Angioplasty Balloon…Boston Scientific Corporation · 2016
- This deviceK241683 Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020…Boston Scientific Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −7 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −6 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −5 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −4 | K080982 | Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters | Boston Scientific Corp | 2008 | — |
| −3 | K093636 | Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters Model… | Boston Scientific Corp | 2009 | — |
| −2 | K111295 | .014 Monorail and Otw Pta Balloon Dilatation Catheters | Boston Scientific Corporation | 2011 | 3 |
| −1 | K162350 | Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation… | Boston Scientific Corporation | 2016 | — |
| 0 (this device) | K241683 | Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 )… | Boston Scientific Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K162350 | Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter…Summary page 7…Angioplasty, Peripheral, Transluminal Regulatory Class: II Product Code: LIT 3. Predicate Device Predicate Device: Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (K162350) Reference Devices: Sterling™ OVER-THE-WIRE PTA Balloon Dilatation Catheter (K141112, K132430, K053116); Sterling™ SL OVER-THE-WI… | 2016 |
| † | K141112 | Sterling Over-the Wire Pta Balloon Dilatation Catheter | 2014 |
| † | K132430 | Sterling Over-the-Wire (Otw) Pta Balloon Dilatation Catheter | 2013 |
| † | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | 2005 |
| † | K093720 | Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 12 ancestors have a recall of any class.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Sterling Monorail PTA 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/K241683 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241683: Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031406020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031408020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031410020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031412020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031415020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H749390314.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241683
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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