510(k) · Cleared
ClearedPeripheral Cutting Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · PNO Catheter, Percutaneous, Cutting/Scoring
Cleared on Jul 1, 2004 as substantially equivalent to K960501 (Boston Scientific Corp, 1996) and 2 other predicates after a 160-day review. Its family tree reaches back 3 generations to 1991. 6 later devices descend from it.
- Decided
- Jul 1, 2004
- Review
- 160 days
- Class
- Class II
- Product code
- PNO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K904275 (1991). 8 ancestors in all, the oldest K896849 (1990). 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK904275 Morse Balloon Inflation DeviceNorth American Instrument Corp. · 1991
- 2 generations backK953676 Breeze Digital Inflation DeviceNamic · 1996
- 1 generation backK022061 Cvsi Peripheral Balloon Catheter; Cvsi InflaterCryo Vascular Systems, Inc. · 2002
- This deviceK040155 Peripheral Cutting BalloonBoston Scientific Corp · 2004
- Descendant · cites it directly · 5 of its ownK041993 2 CM Peripheral Cutting BaloonBoston Scientific Ivt · 2004
- Descendant · cites it directly · 4 of its ownK052038 Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery…Boston Scientific Corporation · 2005 · Recalled
- Descendant · 2 generations on · 3 of its ownK062387 Small Peripheral Cutting Ballon, Monorail Delivery SystemBoston Scientific · 2006
- Descendant · 2 generations on · 2 of its ownK070951 2CM Peripheral Cutting Balloon, Small Peripheral Cutting Balloon…Boston Scientific · 2007
- Descendant · 2 generations on · 1 of its ownK151253 2cm Peripheral Cutting Balloon Microsurgical Dilatation CatheterBoston Scientific Limited · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- 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 · cites it directly4descendants
- K062387Small Peripheral Cutting Ballon, Monorail Delivery SystemBoston Scientific · 2006 · 2 generations on3descendants
- K0709512CM Peripheral Cutting Balloon, Small Peripheral Cutting Balloon with Monorail and…Boston Scientific · 2007 · 2 generations on2descendants
- K1512532cm Peripheral Cutting Balloon Microsurgical Dilatation CatheterBoston Scientific Limited · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904275 | Morse Balloon Inflation Device | North American Instrument Corp. | 1991 | — |
| −2 | K953676 | Breeze Digital Inflation Device | Namic | 1996 | — |
| −1 | K022061 | Cvsi Peripheral Balloon Catheter; Cvsi Inflater | Cryo Vascular Systems, Inc. | 2002 | — |
| 0 (this device) | K040155 | Peripheral Cutting Balloon | Boston Scientific Corp | 2004 | — |
| +1 | K041993 | 2 CM Peripheral Cutting Baloon | Boston Scientific Ivt | 2004 | — |
| +1 | K052038 | Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery System | Boston Scientific Corporation | 2005 | 2 |
| +2 | K062387 | Small Peripheral Cutting Ballon, Monorail Delivery System | Boston Scientific | 2006 | — |
| +2 | K070951 | 2CM Peripheral Cutting Balloon, Small Peripheral Cutting Balloon with Monorail… | Boston Scientific | 2007 | — |
| +2 | K151253 | 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter | Boston Scientific Limited | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 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 PNO? 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 PNO device
- #1 K261778 JADE SCORE PTA Scoring Balloon Dilatation…score 14.1 · 8 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 |
|---|---|---|---|
| * | K960501 | Ultra-Thin Diamond Balloon Dilatation CatheterSummary page 4…oduct Code LIT Classification Class II Proprictary Name Peripheral Cutting Balloon™ Predicate Devices Boston Scientific Ultra-Thin Diamond Balloon Dilatation Catheter, K960501 Polarcath ™ Peripheral Balloon Catheter system, K022061 CVSi Peripheral Balloon Catheter system, K030742 Device Description The… | 1996 |
| * | K022061 | Cvsi Peripheral Balloon Catheter; Cvsi InflaterSummary page 4…Peripheral Cutting Balloon™ Predicate Devices Boston Scientific Ultra-Thin Diamond Balloon Dilatation Catheter, K960501 Polarcath ™ Peripheral Balloon Catheter system, K022061 CVSi Peripheral Balloon Catheter system, K030742 Device Description The Peripheral Cutting Balloon (PCB) is available in nomina… | 2002 |
| * | K030742 | Polarcath Peripheral Balloon Catheter SystemSummary page 4…oston Scientific Ultra-Thin Diamond Balloon Dilatation Catheter, K960501 Polarcath ™ Peripheral Balloon Catheter system, K022061 CVSi Peripheral Balloon Catheter system, K030742 Device Description The Peripheral Cutting Balloon (PCB) is available in nominal balloon diameters of 5.0 mm 10 8.0 mm (Table 1)… | 2003 |
What descends from it? (6)
2 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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K041993 (Boston Scientific Ivt, 2004) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K960501.
How does its category compare?
All PNO devicesPNO Catheter, Percutaneous, Cutting/Scoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PNO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNO
246in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PNO
No recall names PNO since 2007.
Adverse event reports per year · PNO
511in 2025
MAUDE reports naming product code PNO, 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 | 3 | 61 | 0 | 0 |
| 2008 | 4 | 28 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 23 | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 84 | 0 | 0 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 3 | 74 | 0 | 26 |
| 2018 | 0 | — | 0 | 55 |
| 2019 | 1 | — | 0 | 81 |
| 2020 | 4 | 94 | 0 | 121 |
| 2021 | 1 | — | 0 | 90 |
| 2022 | 2 | — | 0 | 75 |
| 2023 | 0 | — | 0 | 304 |
| 2024 | 4 | 246 | 0 | 537 |
| 2025 | 2 | — | 0 | 511 |
| 2026 | 3 | 110 | 0 | — |
What is it indicated for?
The Peripheral Cutting Balloon™ catheters are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of 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/K040155 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040155: Peripheral Cutting Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040155
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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