510(k) · Cleared
ClearedHoper Ptca Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lepu Medical Technology (Beijing) Co., Ltd. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Aug 13, 2013 as substantially equivalent to K110133 (Creganna-Tactx Medical, 2011) and 2 other predicates after a 273-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Aug 13, 2013
- Review
- 273 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to P860019 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backP860019 Scimed Ptca Dilatation CatheterScimed Life Systems, Inc. · 1986 · Recalled
- 1 generation backK110133 Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation…Creganna-Tactx Medical · 2011 · Recalled
- This deviceK123473 Hoper Ptca Balloon CatheterLepu Medical Technology (Beijing) Co., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P860019 | Scimed Ptca Dilatation Catheter | Scimed Life Systems, Inc. | 1986 | 5 |
| −1 | K110133 | Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter | Creganna-Tactx Medical | 2011 | 3 |
| 0 (this device) | K123473 | Hoper Ptca Balloon Catheter | Lepu Medical Technology (Beijing) Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2003 | 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? (3)
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 |
|---|---|---|---|
| * | K110133 | Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter | 2011 |
| * | P880003 | Cordis Ptca Dilatation CatheterSummary page 1…atation Catheter, Creganna Tactx Medical, Inc. (KI 10133), FireStar® PTCA Dilatation Catheter, Cordis - Johnson & Johnson, (P880003), and EX mniniRAlL TmRX PTCA Catheter (P02003 7). Description: Hoper Rapid Exchange (LPRX) Balloo… | 1988 |
| * | P020037 | FX Minirail RX Percutaneous Transluminal Coronary Angioplasty (Ptca) CatheterSummary page 1…(KI 10133), FireStar® PTCA Dilatation Catheter, Cordis - Johnson & Johnson, (P880003), and EX mniniRAlL TmRX PTCA Catheter (P02003 7). Description: Hoper Rapid Exchange (LPRX) Balloon Dilatation Catheter is a Percutaneous Translum… | 2003 |
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 3 companies; a new generation was cleared every 24.5 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 4 other devices also cite its predicate K110133.
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 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.
This balloon dilatation catheter is not intended for the expansion or delivery of a stent.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123473 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123473: Hoper Ptca Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123473
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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