510(k) · Cleared
ClearedUltra-Thin Diamond 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 9, 1996 after a 67-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Apr 9, 1996
- Review
- 67 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK960501 Ultra-Thin Diamond Balloon Dilatation CatheterBoston Scientific Corp · 1996
- Descendant · cites it directly · 6 of its ownK040155 Peripheral Cutting BalloonBoston Scientific Corp · 2004
- Descendant · cites it directly · 5 of its ownK051254 Peripheral Cutting BalloonBoston Scientific Ivt · 2005
- Descendant · cites it directly · 5 of its ownK041993 2 CM Peripheral Cutting BaloonBoston Scientific Ivt · 2004
- Descendant · 2 generations on · 4 of its ownK052038 Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery…Boston Scientific Corporation · 2005 · Recalled
- Descendant · 3 generations on · 3 of its ownK062387 Small Peripheral Cutting Ballon, Monorail Delivery SystemBoston Scientific · 2006
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K040155Peripheral Cutting BalloonBoston Scientific Corp · 2004 · cites it directly6descendants
- K051254Peripheral Cutting BalloonBoston Scientific Ivt · 2005 · cites it directly5descendants
- K0419932 CM Peripheral Cutting BaloonBoston Scientific Ivt · 2004 · cites it directly5descendants
- K052038Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery SystemBoston Scientific Corporation · 2005 · 2 generations on4descendants
- K062387Small Peripheral Cutting Ballon, Monorail Delivery SystemBoston Scientific · 2006 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960501 | Ultra-Thin Diamond Balloon Dilatation Catheter | Boston Scientific Corp | 1996 | — |
| +1 | K040155 | Peripheral Cutting Balloon | Boston Scientific Corp | 2004 | — |
| +1 | K051254 | Peripheral Cutting Balloon | Boston Scientific Ivt | 2005 | — |
| +1 | K041993 | 2 CM Peripheral Cutting Baloon | Boston Scientific Ivt | 2004 | — |
| +2 | K052038 | Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery System | Boston Scientific Corporation | 2005 | 2 |
| +3 | K062387 | Small Peripheral Cutting Ballon, Monorail Delivery System | Boston Scientific | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | — | Blue Max Balloon Dilatation Catheter Named without a submission number | |
| * | — | Ultra-thin™ Balloon Catheter Named without a submission number | |
| * | — | Symmetry™ Small Vessel Balloon Dilatation Catheter Named without a submission number | |
| * | — | Courier™ Balloon Dilatation Catheter Named without a submission number |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K040155 (Boston Scientific Corp, 2004) has gone furthest, with 6 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 Diamond™ Vessel Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistalae.
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/K960501 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960501: Ultra-Thin Diamond 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/K960501
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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