510(k) · Cleared
ClearedDK-Ptca Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuit Medical, LLC · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Jan 16, 2013 as substantially equivalent to K111544 (Trireme Medical, Inc., 2012) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Jan 16, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P860019 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backP860019 Scimed Ptca Dilatation CatheterScimed Life Systems, Inc. · 1986 · Recalled
- 2 generations backK110133 Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation…Creganna-Tactx Medical · 2011 · Recalled
- 1 generation backK111544 Glider Ptca Balloon CatheterTrireme Medical, Inc. · 2012
- This deviceK123264 DK-Ptca Balloon CatheterIntuit Medical, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P860019 | Scimed Ptca Dilatation Catheter | Scimed Life Systems, Inc. | 1986 | 5 |
| −2 | K110133 | Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter | Creganna-Tactx Medical | 2011 | 3 |
| −1 | K111544 | Glider Ptca Balloon Catheter | Trireme Medical, Inc. | 2012 | — |
| 0 (this device) | K123264 | DK-Ptca Balloon Catheter | Intuit Medical, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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 LOX? 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 LOX device
- #1 K254022 FLASH Flex™ Aorto-Ostial Angioplasty Systemscore 12.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K111544 | Glider Ptca Balloon CatheterSummary page 4…ngioplasty Catheter Classification: Percutaneous Transluminal Coronary Angioplasty Catheter LOX, 21 CFR 870.5100(a) Predicate Device(s): Glider™ PTCA Balloon Catheter, K111544 " EMPIRA™ & EMPIRA™ NC Balloon Catheters, K110133 Physical Description: The DK-PTCA Balloon Catheter is a torqueable, rapid-ex… | 2012 |
| * | K110133 | Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation CatheterSummary page 4…ransluminal Coronary Angioplasty Catheter LOX, 21 CFR 870.5100(a) Predicate Device(s): Glider™ PTCA Balloon Catheter, K111544 " EMPIRA™ & EMPIRA™ NC Balloon Catheters, K110133 Physical Description: The DK-PTCA Balloon Catheter is a torqueable, rapid-exchange, percutaneous transluminal coronary angiopla… | 2011 |
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 27 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 3 of the 4 ancestors have a recall of any class.
- 3 other devices also cite its predicate K111544.
How does its category compare?
All LOX devicesLOX Catheters, Transluminal Coronary Angioplasty, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LOX
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LOX
241in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOX
4in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOX
1,890in 2025
MAUDE reports naming product code LOX, 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 | 19 | — | 1 | 1,053 |
| 2008 | 22 | — | 80 | 1,063 |
| 2009 | 28 | — | 0 | 1,353 |
| 2010 | 32 | — | 0 | 1,392 |
| 2011 | 9 | 103 | 0 | 2,090 |
| 2012 | 10 | 120 | 0 | 2,092 |
| 2013 | 6 | 123 | 0 | 2,436 |
| 2014 | 6 | 166 | 0 | 2,316 |
| 2015 | 4 | 119 | 0 | 2,060 |
| 2016 | 9 | 116 | 0 | 2,578 |
| 2017 | 6 | 113 | 0 | 2,753 |
| 2018 | 7 | 80 | 0 | 2,225 |
| 2019 | 1 | — | 4 | 2,102 |
| 2020 | 1 | — | 0 | 1,974 |
| 2021 | 6 | 167 | 0 | 1,738 |
| 2022 | 5 | 121 | 0 | 1,816 |
| 2023 | 4 | 138 | 0 | 1,720 |
| 2024 | 4 | 241 | 0 | 1,804 |
| 2025 | 0 | — | 0 | 1,890 |
| 2026 | 6 | 156 | 0 | — |
What is it indicated for?
The Intuit Medical, LLC, DK-PTCA Balloon Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
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/K123264 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123264: DK-Ptca Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123264
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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