510(k) · Cleared
ClearedFLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ostial Corporation · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Feb 16, 2016 as substantially equivalent to K131450 (Ostial Corporation, 2013) after a 169-day review. Its family tree reaches back 4 generations to 2011. 1 later device descends from it.
- Decided
- Feb 16, 2016
- Review
- 169 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K111284 (2011). 5 ancestors in all, the oldest P860019 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK111284 Flash-C Ptca Balloon Dilation Catheter - 5MM X 19MM X 135CM / 6MM X…Ostial Corporation · 2011
- 3 generations backK113775 Flash-C Ptca Balloon Dilatation Catheter- 4.0MM X 14MM X 135CM…Ostial Corporation · 2012
- 2 generations backK122178 Flash-C Ptca Balloon Dilatation Catheter - 4MM X 14MM X 135CM…Ostial Corporation · 2012
- 1 generation backK131450 Flash Mini Ostial System - 3.0MM X 135CM, Flash Mini Ostial System -…Ostial Corporation · 2013
- This deviceK152485 FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial…Ostial Corporation · 2016
- Descendant · cites it directly · 0 of its ownK254022 FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K111284 | Flash-C Ptca Balloon Dilation Catheter - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM | Ostial Corporation | 2011 | — |
| −3 | K113775 | Flash-C Ptca Balloon Dilatation Catheter- 4.0MM X 14MM X 135CM -4.0MM X 19MM X… | Ostial Corporation | 2012 | — |
| −2 | K122178 | Flash-C Ptca Balloon Dilatation Catheter - 4MM X 14MM X 135CM, Flash-C Ptca… | Ostial Corporation | 2012 | — |
| −1 | K131450 | Flash Mini Ostial System - 3.0MM X 135CM, Flash Mini Ostial System - 3.5MM X… | Ostial Corporation | 2013 | — |
| 0 (this device) | K152485 | FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System -… | Ostial Corporation | 2016 | — |
| +1 | K254022 | FLASH Flex™ Aorto-Ostial Angioplasty System | Verge Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K131450 | Flash Mini Ostial System - 3.0MM X 135CM, Flash Mini Ostial System - 3.5MM X 8MM X…Summary page 4…870.5100 C. Predicate Device Name Proprietary Name: FLASH Mini Ostial System 510(k) #'s: K131450 Common/Usual Name: PTCA Catheter Classification Name: Catheters,… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254022 | FLASH Flex™ Aorto-Ostial Angioplasty System | 2026 | 0 |
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 5 years and passes through 1 company; a new generation was cleared every 10 months on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K254022 (Verge Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
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. 2016, 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 FLASH Mini Ostial System is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The FLASH Mini Ostial System is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152485 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152485: FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152485
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