510(k) · Cleared
ClearedFlash-C Ptca Balloon Dilatation Catheter - 4MM X 14MM X 135CM, Flash-C Ptca Balloon Dilatation Catheter - 4MM X 19MM X 1
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 Oct 11, 2012 as substantially equivalent to P860019 (Scimed Life Systems, Inc., 1986) and 1 other predicate after an 80-day review. Its family tree reaches back 2 generations to 2011. 3 later devices descend from it.
- Decided
- Oct 11, 2012
- Review
- 80 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K111284 (2011). 3 ancestors in all, the oldest P860019 (1986). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK111284 Flash-C Ptca Balloon Dilation Catheter - 5MM X 19MM X 135CM / 6MM X…Ostial Corporation · 2011
- 1 generation backK113775 Flash-C Ptca Balloon Dilatation Catheter- 4.0MM X 14MM X 135CM…Ostial Corporation · 2012
- This deviceK122178 Flash-C Ptca Balloon Dilatation Catheter - 4MM X 14MM X 135CM…Ostial Corporation · 2012
- Descendant · cites it directly · 2 of its ownK131450 Flash Mini Ostial System - 3.0MM X 135CM, Flash Mini Ostial System -…Ostial Corporation · 2013
- Descendant · 2 generations on · 1 of its ownK152485 FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial…Ostial Corporation · 2016
- Descendant · 3 generations on · 0 of its ownK254022 FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See all- K131450Flash Mini Ostial System - 3.0MM X 135CM, Flash Mini Ostial System - 3.5MM X 8MM X…Ostial Corporation · 2013 · cites it directly2descendants
- K152485FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x…Ostial Corporation · 2016 · 2 generations on1descendant
- K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K111284 | Flash-C Ptca Balloon Dilation Catheter - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM | Ostial Corporation | 2011 | — |
| −1 | K113775 | Flash-C Ptca Balloon Dilatation Catheter- 4.0MM X 14MM X 135CM -4.0MM X 19MM X… | Ostial Corporation | 2012 | — |
| 0 (this device) | 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 | — |
| +2 | K152485 | FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System -… | Ostial Corporation | 2016 | — |
| +3 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | P860019 | Scimed Ptca Dilatation CatheterSummary page 1…Predicate: Trade Name(s): Maverick XL Monorail PTCA Dilatation Catheter, P8600 19/S 183 Classification Name: Catheters, Transluminal Coronary Angioplasty,… | 1986 |
| * | K113775 | Flash-C Ptca Balloon Dilatation Catheter- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM-…Summary page 1…1 CER 870.5 100, Product Code LOX) Secondary Predicate: Trade Name(s): Flash-C PTCA Balloon Dilatation Catheter, KI 113775 Classification Name: Catheters, Transluminal Coronary Angioplasty,… | 2012 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131450 | Flash Mini Ostial System - 3.0MM X 135CM, Flash Mini Ostial System - 3.5MM X 8MM X… | 2013 | 2 |
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 1 year and passes through 1 company; a new generation was cleared every 10 months on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K131450 (Ostial Corporation, 2013) has gone furthest, with 2 descendants of its own.
- 20 other devices also cite its predicate P860019.
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. 2012, 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-C PTCA Balloon Dilatation Catheter 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-C PTCA Balloon Dilatation Catheter 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/K122178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122178: Flash-C Ptca Balloon Dilatation Catheter - 4MM X 14MM X 135CM, Flash-C Ptca Balloon Dilatation Catheter - 4MM X 19MM X 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122178
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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