510(k) · Cleared
ClearedPOT PTCA Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brosmed Medical Co., Ltd. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Apr 11, 2023 as substantially equivalent to K133852 (Brosmed Medical, 2014) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 1980.
- Decided
- Apr 11, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P790017 (1980). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backP790017 Usci Dilatation CatheterMedtronic, Ireland · 1980
- 2 generations backK133852 Apollo Balloon Dilatation CatheterBrosmed Medical · 2014
- 1 generation backK153742 Apollo Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2016
- This deviceK230705 POT PTCA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P790017 | Usci Dilatation Catheter | Medtronic, Ireland | 1980 | — |
| −2 | K133852 | Apollo Balloon Dilatation Catheter | Brosmed Medical | 2014 | — |
| −1 | K153742 | Apollo Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2016 | — |
| 0 (this device) | K230705 | POT PTCA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K133852 | Apollo Balloon Dilatation CatheterSummary page 5…Product Code: LOX Review Panel: Cardiovascular 3. PREDICATE DEVICE Apollo Balloon Dilatation Catheter (K133852 and K153742). 4. DESCRIPTION OF THE DEVICE The POT PTCA balloon dilatation catheter is a sterile, flexible tube designed to be… | 2014 |
| * | K153742 | Apollo Balloon Dilatation CatheterSummary page 5…t Code: LOX Review Panel: Cardiovascular 3. PREDICATE DEVICE Apollo Balloon Dilatation Catheter (K133852 and K153742). 4. DESCRIPTION OF THE DEVICE The POT PTCA balloon dilatation catheter is a sterile, flexible tube designed to be used in per… | 2016 |
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 43 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K133852.
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. 2023, 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 POT PTCA balloon dilatation catheter is indicated for:
·balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion
·balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
·balloon dilatation of a stent after implantation (balloon models Ø2.25 mm - Ø5.00 mm only)
Note: Bench testing was conducted with the POT PTCA Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers’ stents due to difference in stent design.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230705 · printed Nov 3, 2026
Cite this page
510(k) Report. “K230705: POT PTCA Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K230705
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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