510(k) · Cleared
ClearedSterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon Dilatation Catheters Model Vario
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 Dec 23, 2009 as substantially equivalent to K080982 (Boston Scientific Corp, 2008) and 2 other predicates after a 21-day review. Its family tree reaches back 5 generations to 2000. 21 later devices descend from it.
- Decided
- Dec 23, 2009
- Review
- 21 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K001134 (2000). 6 ancestors in all. 21 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 4 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 3 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 2 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 1 generation backK080982 Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation…Boston Scientific Corp · 2008
- This deviceK093720 Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL…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 · cites it directly · 8 of its ownK141150 Pta Balloon Dilatation CatheterBoston Scientific Corp · 2014
- Descendant · 2 generations on · 3 of its ownK173894 Jade PTA Balloon Dilatation CatheterOrbusneich Medical Trading, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK140351 Arrow Gpscath Balloon Dilatation CatheterHotspur Technologies,Inc Subsidiary of Teleflex ME · 2014
- Descendant · cites it directly · 3 of its ownK120805 Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2012
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K111295.014 Monorail and Otw Pta Balloon Dilatation CathetersBoston Scientific Corporation · 2011 · cites it directly9descendants
- K141150Pta Balloon Dilatation CatheterBoston Scientific Corp · 2014 · cites it directly8descendants
- K173894Jade PTA Balloon Dilatation CatheterOrbusneich Medical Trading, Inc. · 2018 · 2 generations on3descendants
- K140351Arrow Gpscath Balloon Dilatation CatheterHotspur Technologies,Inc Subsidiary of Teleflex ME · 2014 · 2 generations on3descendants
- K120805Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd. · 2012 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −4 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −3 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −2 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −1 | K080982 | Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters | Boston Scientific Corp | 2008 | — |
| 0 (this device) | K093720 | Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL… | Boston Scientific Corp | 2009 | — |
| +1 | K111295 | .014 Monorail and Otw Pta Balloon Dilatation Catheters | Boston Scientific Corporation | 2011 | 3 |
| +1 | K141150 | Pta Balloon Dilatation Catheter | Boston Scientific Corp | 2014 | — |
| +2 | K173894 | Jade PTA Balloon Dilatation Catheter | Orbusneich Medical Trading, Inc. | 2018 | — |
| +2 | K140351 | Arrow Gpscath Balloon Dilatation Catheter | Hotspur Technologies,Inc Subsidiary of Teleflex ME | 2014 | — |
| +1 | K120805 | Proteus Pta Balloon Catheter with Embolic Capture Feature | Angioslide, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K080982 | Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation CathetersSummary page 1…PTA Balloon Dilatation Catheters line extension design, materials, manufacturing process and intended use are substantially equivalent to predicate devices Sterling ES (K080982), Sterling Monorail (K<053118), Sterling OTW (K0531 16) Performance Data The substantial equivalence of the modified Sterling PTA… | 2008 |
| * | K053118 | Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-XxxxxxSummary page 1…rs line extension design, materials, manufacturing process and intended use are substantially equivalent to predicate devices Sterling ES (K080982), Sterling Monorail (K<053118), Sterling OTW (K0531 16) Performance Data The substantial equivalence of the modified Sterling PTA Balloon Dilatation Catheters… | 2005 |
| * | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxSummary page 1…n, materials, manufacturing process and intended use are substantially equivalent to predicate devices Sterling ES (K080982), Sterling Monorail (K<053118), Sterling OTW (K0531 16) Performance Data The substantial equivalence of the modified Sterling PTA Balloon Dilatation Catheters is demonstrated with desi… | 2005 |
| * | — | Polarcath Peripheral Dilatation System Named without a submission number |
What descends from it? (21)
See all 214 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111295 | .014 Monorail and Otw Pta Balloon Dilatation Catheters | 2011 | 9 |
| K141150 | Pta Balloon Dilatation Catheter | 2014 | 8 |
| K120805 | Proteus Pta Balloon Catheter with Embolic Capture Feature | 2012 | 3 |
| K162350 | Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter… | 2016 | 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 9 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K111295 (Boston Scientific Corporation, 2011) has gone furthest, with 9 descendants of its own.
- 5 other devices also cite its predicate K080982.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 SL PTA Balloon Dilatation Catheter is indicated for Percutaneous Trarisluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femnoral, infrapc'pliteal, popliteal, renal arteries, and for the treatment of obstructive lesions c::f native or synthetic arteriovenous dialysis fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093720 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093720: Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon Dilatation Catheters Model Vario.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093720
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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