510(k) · Cleared
Recalled · Class II · 2025.014 Monorail and Otw Pta Balloon Dilatation Catheters
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 May 31, 2011 as substantially equivalent to K080982 (Boston Scientific Corp, 2008) and 2 other predicates after a 21-day review. Its family tree reaches back 6 generations to 2000. 9 later devices descend from it. It has been recalled 3 times.
- Decided
- May 31, 2011
- Review
- 21 days
- Class
- Class II
- Product code
- LIT
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 6 generations to K001134 (2000). 8 ancestors in all. 9 later devices descend from it, 4 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 backK093636 Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation…Boston Scientific Corp · 2009
- This deviceK111295 .014 Monorail and Otw Pta Balloon Dilatation CathetersBoston Scientific Corporation · 2011
- Descendant · cites it directly · 3 of its ownK140351 Arrow Gpscath Balloon Dilatation CatheterHotspur Technologies,Inc Subsidiary of Teleflex ME · 2014
- Descendant · cites it directly · 1 of its ownK162350 Coyote Monorail Percutaneous Transluminal Angioplasty Balloon…Boston Scientific Corporation · 2016
- Descendant · cites it directly · 1 of its ownK150452 ComboCath OTW PTA Dilatation CatheterSumma Therapeutics, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK142300 Arrow GPSCath Balloon Dialation Catheter (150 cm)Hotspur Technologies, Inc., · 2014
- Descendant · 2 generations on · 0 of its ownK241683 Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020…Boston Scientific Corporation · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K140351Arrow Gpscath Balloon Dilatation CatheterHotspur Technologies,Inc Subsidiary of Teleflex ME · 2014 · cites it directly3descendants
- K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter…Boston Scientific Corporation · 2016 · cites it directly1descendant
- K150452ComboCath OTW PTA Dilatation CatheterSumma Therapeutics, LLC · 2015 · cites it directly1descendant
- K142300Arrow GPSCath Balloon Dialation Catheter (150 cm)Hotspur Technologies, Inc., · 2014 · 2 generations on1descendant
- K241683Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™…Boston Scientific Corporation · 2024 · 2 generations on0descendants
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 | K093636 | Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters Model… | Boston Scientific Corp | 2009 | — |
| 0 (this device) | K111295 | .014 Monorail and Otw Pta Balloon Dilatation Catheters | Boston Scientific Corporation | 2011 | — |
| +1 | K140351 | Arrow Gpscath Balloon Dilatation Catheter | Hotspur Technologies,Inc Subsidiary of Teleflex ME | 2014 | — |
| +1 | K162350 | Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation… | Boston Scientific Corporation | 2016 | — |
| +1 | K150452 | ComboCath OTW PTA Dilatation Catheter | Summa Therapeutics, LLC | 2015 | — |
| +2 | K142300 | Arrow GPSCath Balloon Dialation Catheter (150 cm) | Hotspur Technologies, Inc., | 2014 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K080982 | Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation CathetersSummary page 1…alence The .014 PTA Balloon Dilatation Catheters design, materials, manufacturing process and intended use are substantially equivalent to predicate devices Sterling ES (K080982 and K093636), and Sterling SL Monorail and OTW (K093720) PTA Catheters. Comparison of Technological Characteristics The .014 PT… | 2008 |
| * | K093636 | Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters Model…Summary page 1…014 PTA Balloon Dilatation Catheters design, materials, manufacturing process and intended use are substantially equivalent to predicate devices Sterling ES (K080982 and K093636), and Sterling SL Monorail and OTW (K093720) PTA Catheters. Comparison of Technological Characteristics The .014 PTA Balloon Di… | 2009 |
| * | K093720 | Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon…Summary page 1…materials, manufacturing process and intended use are substantially equivalent to predicate devices Sterling ES (K080982 and K093636), and Sterling SL Monorail and OTW (K093720) PTA Catheters. Comparison of Technological Characteristics The .014 PTA Balloon Dilatation Catheter incorporates substantially… | 2009 |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140351 | Arrow Gpscath Balloon Dilatation Catheter | 2014 | 3 |
| K162350 | Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter… | 2016 | 1 |
| K150452 | ComboCath OTW PTA Dilatation Catheter | 2015 | 1 |
| K134031 | Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation… | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 3, 2025 | Class II | Z-1042-2026 | Process change control | Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during… |
| Feb 4, 2014 | Class II | Z-0971-2014 | Device Design | Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the… |
| Feb 4, 2014 | Class II | Z-0969-2014 | Device Design | Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K140351 (Hotspur Technologies,Inc Subsidiary of Teleflex ME, 2014) has gone furthest, with 3 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. 2011, 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?
.014 PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, infrapopliteal, popliteal, renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111295: .014 Monorail and Otw 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/K111295
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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