510(k) · Cleared
Recalled · 2005Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery System
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 Aug 16, 2005 as substantially equivalent to K051254 (Boston Scientific Ivt, 2005) and 2 other predicates after a 19-day review. Its family tree reaches back 5 generations to 1991. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 16, 2005
- Review
- 19 days
- Class
- Class II
- Product code
- LIT
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 5 generations to K904275 (1991). 11 ancestors in all, the oldest K896849 (1990). 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK904275 Morse Balloon Inflation DeviceNorth American Instrument Corp. · 1991
- 4 generations backK953676 Breeze Digital Inflation DeviceNamic · 1996
- 3 generations backK022061 Cvsi Peripheral Balloon Catheter; Cvsi InflaterCryo Vascular Systems, Inc. · 2002
- 2 generations backK040155 Peripheral Cutting BalloonBoston Scientific Corp · 2004
- 1 generation backK041993 2 CM Peripheral Cutting BaloonBoston Scientific Ivt · 2004
- This deviceK052038 Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery…Boston Scientific Corporation · 2005
- Descendant · cites it directly · 3 of its ownK062387 Small Peripheral Cutting Ballon, Monorail Delivery SystemBoston Scientific · 2006
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 0 of its ownK232207 D·Kutting™ PTA Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K062387Small Peripheral Cutting Ballon, Monorail Delivery SystemBoston Scientific · 2006 · cites it directly3descendants
- K0709512CM Peripheral Cutting Balloon, Small Peripheral Cutting Balloon with Monorail and…Boston Scientific · 2007 · cites it directly2descendants
- K1512532cm Peripheral Cutting Balloon Microsurgical Dilatation CatheterBoston Scientific Limited · 2015 · 2 generations on1descendant
- K232207D·Kutting™ PTA Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904275 | Morse Balloon Inflation Device | North American Instrument Corp. | 1991 | — |
| −4 | K953676 | Breeze Digital Inflation Device | Namic | 1996 | — |
| −3 | K022061 | Cvsi Peripheral Balloon Catheter; Cvsi Inflater | Cryo Vascular Systems, Inc. | 2002 | — |
| −2 | K040155 | Peripheral Cutting Balloon | Boston Scientific Corp | 2004 | — |
| −1 | K041993 | 2 CM Peripheral Cutting Baloon | Boston Scientific Ivt | 2004 | — |
| 0 (this device) | K052038 | Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery System | Boston Scientific Corporation | 2005 | — |
| +1 | K062387 | Small Peripheral Cutting Ballon, Monorail Delivery System | Boston Scientific | 2006 | — |
| +1 | 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 | — |
| +3 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K051254 | Peripheral Cutting BalloonSummary page 4…on: small Monorail and Over-the-Wire Delivery Systems (PCB: small MR and OTW). Proprietary Names Predicate Devices Boston Scientific small Peripheral Cutting Batloon; K051254 Boston Scientific 1 ¢cm Peripheral Cutting Balloon; K051254 and K040155 Boston Scientific 2 cm Peripheral Cutting Balloon; K0512… | 2005 |
| * | K040155 | Peripheral Cutting BalloonSummary page 4…OTW). Proprietary Names Predicate Devices Boston Scientific small Peripheral Cutting Batloon; K051254 Boston Scientific 1 ¢cm Peripheral Cutting Balloon; K051254 and K040155 Boston Scientific 2 cm Peripheral Cutting Balloon; K051254 and K041993 Device Description ‘The PCB: small MR and OTW features a… | 2004 |
| * | K041993 | 2 CM Peripheral Cutting BaloonSummary page 4…ripheral Cutting Batloon; K051254 Boston Scientific 1 ¢cm Peripheral Cutting Balloon; K051254 and K040155 Boston Scientific 2 cm Peripheral Cutting Balloon; K051254 and K041993 Device Description ‘The PCB: small MR and OTW features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitu… | 2004 |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 7, 2005 | Not classified | Z-0409-06 | Other | The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft… |
| Dec 7, 2005 | Not classified | Z-0410-06 | Other | The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K062387 (Boston Scientific, 2006) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K051254.
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 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/K052038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052038: Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052038
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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