510(k) · Cleared
ClearedD·Kutting™ PTA Scoring Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dk Medical Technology Co., Ltd. · PNO Catheter, Percutaneous, Cutting/Scoring
Cleared on Mar 7, 2024 as substantially equivalent to K151253 (Boston Scientific Limited, 2015) after a 225-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Mar 7, 2024
- Review
- 225 days
- Class
- Class II
- Product code
- PNO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K904275 (1991). 15 ancestors in all, the oldest K896849 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK904275 Morse Balloon Inflation DeviceNorth American Instrument Corp. · 1991
- 5 generations between
- 3 generations backK062387 Small Peripheral Cutting Ballon, Monorail Delivery SystemBoston Scientific · 2006
- 2 generations backK070951 2CM Peripheral Cutting Balloon, Small Peripheral Cutting Balloon…Boston Scientific · 2007
- 1 generation backK151253 2cm Peripheral Cutting Balloon Microsurgical Dilatation CatheterBoston Scientific Limited · 2015
- This deviceK232207 D·Kutting™ PTA Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd. · 2024
Show all 9 generations
- Root · 9 generations backK904275 Morse Balloon Inflation DeviceNorth American Instrument Corp. · 1991
- 8 generations backK953676 Breeze Digital Inflation DeviceNamic · 1996
- 7 generations backK022061 Cvsi Peripheral Balloon Catheter; Cvsi InflaterCryo Vascular Systems, Inc. · 2002
- 6 generations backK040155 Peripheral Cutting BalloonBoston Scientific Corp · 2004
- 5 generations backK041993 2 CM Peripheral Cutting BaloonBoston Scientific Ivt · 2004
- 4 generations backK052038 Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery…Boston Scientific Corporation · 2005 · Recalled
- 3 generations backK062387 Small Peripheral Cutting Ballon, Monorail Delivery SystemBoston Scientific · 2006
- 2 generations backK070951 2CM Peripheral Cutting Balloon, Small Peripheral Cutting Balloon…Boston Scientific · 2007
- 1 generation backK151253 2cm Peripheral Cutting Balloon Microsurgical Dilatation CatheterBoston Scientific Limited · 2015
- This deviceK232207 D·Kutting™ PTA Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K904275 | Morse Balloon Inflation Device | North American Instrument Corp. | 1991 | — |
| −8 | K953676 | Breeze Digital Inflation Device | Namic | 1996 | — |
| −7 | K022061 | Cvsi Peripheral Balloon Catheter; Cvsi Inflater | Cryo Vascular Systems, Inc. | 2002 | — |
| −6 | K040155 | Peripheral Cutting Balloon | Boston Scientific Corp | 2004 | — |
| −5 | K041993 | 2 CM Peripheral Cutting Baloon | Boston Scientific Ivt | 2004 | — |
| −4 | 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 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K151253 | 2cm Peripheral Cutting Balloon Microsurgical Dilatation CatheterSummary page 5…2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter Device classification name Percutaneous Cutting/Scoring Catheter 510(k) number K151253 Regulation number 21 CFR Part 870.1250 Product code PNO Classification Class II… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 15 ancestors has a recall of any class.
How does its category compare?
All PNO devicesPNO Catheter, Percutaneous, Cutting/Scoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 D·Kutting™ PTA Scoring Balloon Dilatation catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232207: D·Kutting™ PTA Scoring Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232207
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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