510(k) · Cleared
ClearedFirefighter™ Pro PTCA Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai MicroPort Medical (Group) Co., Ltd. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Apr 7, 2026 as substantially equivalent to K180040 (Abbott Vascular, 2018) after a 274-day review. Its family tree reaches back 2 generations to 2010. 2 of the 9 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 7, 2026
- Review
- 274 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K103153 (2010). 8 ancestors in all. No later device cites it as a predicate yet. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK103153 Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary…Abbott Vascular-Cardiac Therapies · 2010 · Recalled (Class I)
- 1 generation backK180040 NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary…Abbott Vascular · 2018
- This deviceK252116 Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K103153 | Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary Dilatation… | Abbott Vascular-Cardiac Therapies | 2010 | Class I |
| −1 | K180040 | NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation… | Abbott Vascular | 2018 | — |
| 0 (this device) | K252116 | Firefighter™ Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 1 |
| 2012 | 2 | 0 |
| 2013 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K180040 | NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter…Summary page 5…ation: Class II, 21 CFR Part 870.5100 Product Code: LOX Predicate Device: TREK™ & MINI TREK™ RX Coronary Dilatation Catheter (K180040) Device Description: FirefighterTM Pro PTCA Balloon Catheter (hereinafter FirefighterTM Pro) is a rapid… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K110134NC Trek RX Coronary Dilatation CatheterAbbott Vascular-Cardiac Therapies · 2011 · 2 generations back · ◆ in the 2011 ancestors bar of FIG. 117 Class I recalls
- K103153Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary Dilatation CatheterAbbott Vascular-Cardiac Therapies · 2010 · 2 generations back · ◆ on the line of descent in FIG. 120 Class I recalls
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- 2 of the 8 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K180040.
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. 2026, 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?
Firefighter Pro PTCA Balloon Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252116: Firefighter™ Pro PTCA Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252116
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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