510(k) · Cleared
ClearedSterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters
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 Jul 14, 2008 as substantially equivalent to K053116 (Boston Scientific Corp, 2005) after a 98-day review. Its family tree reaches back 4 generations to 2000. 35 later devices descend from it.
- Decided
- Jul 14, 2008
- Review
- 98 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001134 (2000). 35 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 3 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 2 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 1 generation backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- This deviceK080982 Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation…Boston Scientific Corp · 2008
- Descendant · cites it directly · 21 of its ownK093720 Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL…Boston Scientific Corp · 2009
- Descendant · cites it directly · 10 of its ownK093636 Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation…Boston Scientific Corp · 2009
- Descendant · cites it directly · 9 of its ownK111295 .014 Monorail and Otw Pta Balloon Dilatation CathetersBoston Scientific Corporation · 2011 · Recalled
- Descendant · 2 generations on · 8 of its ownK141150 Pta Balloon Dilatation CatheterBoston Scientific Corp · 2014
- Descendant · cites it directly · 8 of its ownK101062 Glider Pta Balloon CatheterTrireme Medical, Inc. · 2010
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K093720Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon…Boston Scientific Corp · 2009 · cites it directly21descendants
- K093636Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters Model…Boston Scientific Corp · 2009 · cites it directly10descendants
- K111295.014 Monorail and Otw Pta Balloon Dilatation CathetersBoston Scientific Corporation · 2011 · cites it directly9descendants
- K141150Pta Balloon Dilatation CatheterBoston Scientific Corp · 2014 · 2 generations on8descendants
- K101062Glider Pta Balloon CatheterTrireme Medical, Inc. · 2010 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −3 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −2 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −1 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| 0 (this device) | 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 | — |
| +1 | K093636 | Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters Model… | Boston Scientific Corp | 2009 | — |
| +1 | K111295 | .014 Monorail and Otw Pta Balloon Dilatation Catheters | Boston Scientific Corporation | 2011 | 3 |
| +2 | K141150 | Pta Balloon Dilatation Catheter | Boston Scientific Corp | 2014 | — |
| +1 | K101062 | Glider Pta Balloon Catheter | Trireme Medical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxSummary page 1…PTA Balloon Dilatation Catheter Product Code LIT Classification of Class II, 21 CFR Part 870.1250 Device Predicate Device Sterling OTW PTA K0531 16 December 16, 2005 Balloon Dilatation Catheter Device The St… | 2005 |
What descends from it? (35)
See all 356 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093720 | Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon… | 2009 | 21 |
| K093636 | Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters Model… | 2009 | 10 |
| K111295 | .014 Monorail and Otw Pta Balloon Dilatation Catheters | 2011 | 9 |
| K101062 | Glider Pta Balloon Catheter | 2010 | 8 |
| K094019 | Glider Pta Balloon Catheter | 2010 | 4 |
| K110604 | VBB System | 2011 | 1 |
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 8 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K093720 (Boston Scientific Corp, 2009) has gone furthest, with 21 descendants of its own.
- 5 other devices also cite its predicate K053116.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 ES MR and OTW PTA Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The 2.00 mm - 4.00 mm balloon devices are 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/K080982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080982: Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080982
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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