510(k) · Cleared
Cleared2CM Peripheral Cutting Balloon, Small Peripheral Cutting Balloon with Monorail and Over-the-Wire Delivery Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · PNO Catheter, Percutaneous, Cutting/Scoring
Cleared on Jun 4, 2007 as substantially equivalent to K041993 (Boston Scientific Ivt, 2004) and 3 other predicates after a 61-day review. Its family tree reaches back 7 generations to 1991. 2 later devices descend from it.
- Decided
- Jun 4, 2007
- Review
- 61 days
- Class
- Class II
- Product code
- PNO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K904275 (1991). 13 ancestors in all, the oldest K896849 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK904275 Morse Balloon Inflation DeviceNorth American Instrument Corp. · 1991
- 6 generations backK953676 Breeze Digital Inflation DeviceNamic · 1996
- 5 generations backK022061 Cvsi Peripheral Balloon Catheter; Cvsi InflaterCryo Vascular Systems, Inc. · 2002
- 4 generations backK040155 Peripheral Cutting BalloonBoston Scientific Corp · 2004
- 3 generations backK041993 2 CM Peripheral Cutting BaloonBoston Scientific Ivt · 2004
- 2 generations backK052038 Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery…Boston Scientific Corporation · 2005 · Recalled
- 1 generation backK062387 Small Peripheral Cutting Ballon, Monorail Delivery SystemBoston Scientific · 2006
- This deviceK070951 2CM Peripheral Cutting Balloon, Small Peripheral Cutting Balloon…Boston Scientific · 2007
- Descendant · cites it directly · 1 of its ownK151253 2cm Peripheral Cutting Balloon Microsurgical Dilatation CatheterBoston Scientific Limited · 2015
- Descendant · 2 generations on · 0 of its ownK232207 D·Kutting™ PTA Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904275 | Morse Balloon Inflation Device | North American Instrument Corp. | 1991 | — |
| −6 | K953676 | Breeze Digital Inflation Device | Namic | 1996 | — |
| −5 | K022061 | Cvsi Peripheral Balloon Catheter; Cvsi Inflater | Cryo Vascular Systems, Inc. | 2002 | — |
| −4 | K040155 | Peripheral Cutting Balloon | Boston Scientific Corp | 2004 | — |
| −3 | 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 |
| −1 | K062387 | Small Peripheral Cutting Ballon, Monorail Delivery System | Boston Scientific | 2006 | — |
| 0 (this device) | K070951 | 2CM Peripheral Cutting Balloon, Small Peripheral Cutting Balloon with Monorail… | Boston Scientific | 2007 | — |
| +1 | K151253 | 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter | Boston Scientific Limited | 2015 | — |
| +2 | K232207 | D·Kutting™ PTA Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | 2024 | — |
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 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K041993 | 2 CM Peripheral Cutting BaloonSummary page 4…Monorail Delivery System smail Peripheral Cutting Balloon® with Over-the-Wire Delivery System PTA Catheter LIT Class I, 21 CFR Part 870.1250 20m Perlpheral Cuttmg K041993 August 16, 2004 Balloon® K051254 June 22, 2005 Small Penpheral Cutting K052038 August 16, 2005 Balloon® with Monorail Delivery K0… | 2004 |
| * | K051254 | Peripheral Cutting BalloonSummary page 4…Peripheral Cutting Balloon® with Over-the-Wire Delivery System PTA Catheter LIT Class I, 21 CFR Part 870.1250 20m Perlpheral Cuttmg K041993 August 16, 2004 Balloon® K051254 June 22, 2005 Small Penpheral Cutting K052038 August 16, 2005 Balloon® with Monorail Delivery K062387 October 5, 2006 System Smal… | 2005 |
| * | K052038 | Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery SystemSummary page 4…Delivery System PTA Catheter LIT Class I, 21 CFR Part 870.1250 20m Perlpheral Cuttmg K041993 August 16, 2004 Balloon® K051254 June 22, 2005 Small Penpheral Cutting K052038 August 16, 2005 Balloon® with Monorail Delivery K062387 October 5, 2006 System Small Penpheral Cutting K052038 August 16, 2005 B… | 2005 |
| * | K062387 | Small Peripheral Cutting Ballon, Monorail Delivery SystemSummary page 4…t 870.1250 20m Perlpheral Cuttmg K041993 August 16, 2004 Balloon® K051254 June 22, 2005 Small Penpheral Cutting K052038 August 16, 2005 Balloon® with Monorail Delivery K062387 October 5, 2006 System Small Penpheral Cutting K052038 August 16, 2005 Balloon® with Over-the-Wire Dellvery System " The famlly… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151253 | 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter | 2015 | 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 16 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K151253 (Boston Scientific Limited, 2015) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K041993.
How does its category compare?
All PNO devicesPNO Catheter, Percutaneous, Cutting/Scoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 or native 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/K070951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070951: 2CM Peripheral Cutting Balloon, Small Peripheral Cutting Balloon with Monorail and Over-the-Wire Delivery Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070951
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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