510(k) · Cleared
ClearedKardiFlex PTCA Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcaptain Life Science Co., Ltd. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Apr 29, 2021 as substantially equivalent to K163114 (Orbusneich Medical, Inc., 2017) after a 231-day review. Its family tree reaches back 4 generations to 1980.
- Decided
- Apr 29, 2021
- Review
- 231 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to P790017 (1980). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backP790017 Usci Dilatation CatheterMedtronic, Ireland · 1980
- 3 generations backK103808 Sapphire NCOrbusneich Medical, Inc. · 2011
- 2 generations backK162209 Sapphire NC PlusOrbusneich Medical, Inc. · 2016
- 1 generation backK163114 Sapphire II PROOrbusneich Medical, Inc. · 2017
- This deviceK202619 KardiFlex PTCA Balloon Dilatation CatheterMedcaptain Life Science Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P790017 | Usci Dilatation Catheter | Medtronic, Ireland | 1980 | — |
| −3 | K103808 | Sapphire NC | Orbusneich Medical, Inc. | 2011 | — |
| −2 | K162209 | Sapphire NC Plus | Orbusneich Medical, Inc. | 2016 | — |
| −1 | K163114 | Sapphire II PRO | Orbusneich Medical, Inc. | 2017 | — |
| 0 (this device) | K202619 | KardiFlex PTCA Balloon Dilatation Catheter | Medcaptain Life Science Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K163114 | Sapphire II PROSummary page 4…ice The KardiFlexTM PTCA Balloon Dilatation Catheter is substantially equivalent to the following device: Predicate Device: Sapphire II Pro Coronary Dilatation Catheter (K163114, OrbusNeich Medical, Inc.) cleared on May 1, 2017. The following reference devices are used in this submission: Reference Device… | 2017 |
| † | K103657 | Sapphire | 2011 |
| † | K180921 | Sapphire II PRO Balloon Dilatation Catheter | 2018 |
| † | K182699 | Selethru PTCA Balloon Dilatation Catheter | 2018 |
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 41 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 2 other devices also cite its predicate K163114.
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. 2021, 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?
KardiFlex PTCA Balloon Dilatation Catheter is indicated for:
-balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
-balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.
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/K202619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202619: KardiFlex PTCA 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/K202619
Report an extraction error
Are you the manufacturer?
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