510(k) · Cleared
ClearedApollo Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brosmed Medical · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Sep 19, 2014 as substantially equivalent to P790017 (Medtronic, Ireland, 1980) and 3 other predicates after a 274-day review. Its family tree reaches back 1 generation to 1980. 2 later devices descend from it.
- Decided
- Sep 19, 2014
- Review
- 274 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to P790017 (1980). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backP790017 Usci Dilatation CatheterMedtronic, Ireland · 1980
- This deviceK133852 Apollo Balloon Dilatation CatheterBrosmed Medical · 2014
- Descendant · cites it directly · 1 of its ownK153742 Apollo Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK230705 POT PTCA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P790017 | Usci Dilatation Catheter | Medtronic, Ireland | 1980 | — |
| 0 (this device) | K133852 | Apollo Balloon Dilatation Catheter | Brosmed Medical | 2014 | — |
| +1 | K153742 | Apollo Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | P790017 | Usci Dilatation CatheterSummary page 5…transluminal coronary angioplasty, percutaneous (21 CFR 870.5100(a), Product Code LOX) Predicate Devices: NC Sprinter RX (P790017S095; cleared October 10, 2008) Voyager NC (P810046S226; cleared August 21, 2008)… | 1980 |
| * | P810046 | Simpson-Robert Coronary Balloon Dilatation CatheteSummary page 5…870.5100(a), Product Code LOX) Predicate Devices: NC Sprinter RX (P790017S095; cleared October 10, 2008) Voyager NC (P810046S226; cleared August 21, 2008) Quantum Maverick (P860019S182; cleared October 1, 2002)… | 1982 |
| * | P860019 | Scimed Ptca Dilatation CatheterSummary page 5…0017S095; cleared October 10, 2008) Voyager NC (P810046S226; cleared August 21, 2008) Quantum Maverick (P860019S182; cleared October 1, 2002) NC Quantum (P860019S241; cleared April 16, 2010)… | 1986 |
| * | P880003 | Cordis Ptca Dilatation CatheterSummary page 5…rick (P860019S182; cleared October 1, 2002) NC Quantum (P860019S241; cleared April 16, 2010) Dura Star (P880003S089; cleared August 29, 2007) Device Description: The Apollo Balloon Dilatation Catheter is designed to allow easy… | 1988 |
What descends from it? (2)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2014, 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 Apollo Balloon Dilatation Catheter is indicated for:
1. The 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
2. Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
3. Balloon dilatation of a stent after implantation (balloon models 2.00 mm – 5.00 mm only)
Note: Bench testing was conducted with the Apollo 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/K133852 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133852: Apollo Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133852
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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