510(k) · Cleared
ClearedTransluminal 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 Apr 10, 2000 after a 189-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.
- Decided
- Apr 10, 2000
- Review
- 189 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK993305 Transluminal Balloon Dilatation CatheterBoston Scientific Corp · 2000
- Descendant · cites it directly · 15 of its ownK103751 Mustang Balloon Dilatation CathetersBoston Scientific · 2011
- Descendant · 2 generations on · 2 of its ownK113681 Gladiator Pta Balloon Dilation CatheterBoston Scientific · 2012
- Descendant · 2 generations on · 1 of its ownK201170 Athletis PTA Balloon Dilatation CatheterBoston Scientific Corporation · 2020
- Descendant · 2 generations on · 1 of its ownK160256 Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2016
- Descendant · 3 generations on · 1 of its ownK132810 Gladiator Elite Pta Balloon Dilatation CatheterBoston Scientific Corp · 2014
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K103751Mustang Balloon Dilatation CathetersBoston Scientific · 2011 · cites it directly15descendants
- K113681Gladiator Pta Balloon Dilation CatheterBoston Scientific · 2012 · 2 generations on2descendants
- K201170Athletis PTA Balloon Dilatation CatheterBoston Scientific Corporation · 2020 · 2 generations on1descendant
- K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2016 · 2 generations on1descendant
- K132810Gladiator Elite Pta Balloon Dilatation CatheterBoston Scientific Corp · 2014 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993305 | Transluminal Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| +1 | K103751 | Mustang Balloon Dilatation Catheters | Boston Scientific | 2011 | — |
| +2 | K113681 | Gladiator Pta Balloon Dilation Catheter | Boston Scientific | 2012 | — |
| +2 | K201170 | Athletis PTA Balloon Dilatation Catheter | Boston Scientific Corporation | 2020 | — |
| +2 | K160256 | Polux , Minerva and Atropos PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2016 | — |
| +3 | K132810 | Gladiator Elite Pta Balloon Dilatation Catheter | Boston Scientific Corp | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | — | Ultra-thin Diamond™ Balloon Dilatation Catheter Named without a submission number | |
| * | — | Courier ST™ Balloon Dilatation Catheter Named without a submission number |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103751 | Mustang Balloon Dilatation Catheters | 2011 | 15 |
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?
- Of its descendants, K103751 (Boston Scientific, 2011) has gone furthest, with 15 descendants of its own.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Semi-Compliant 35 Balloon Dilitation Catheter is indicated for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993305 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993305: Transluminal Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993305
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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