510(k) · Cleared
ClearedFlash Pta Ballon Dilatation Catheter-5MM X 19MM X 135CM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ostial Corporation · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Jun 29, 2012 as substantially equivalent to K053118 (Boston Scientific Corp, 2005) and 1 other predicate after a 72-day review. Its family tree reaches back 6 generations to 2000. 3 later devices descend from it.
- Decided
- Jun 29, 2012
- Review
- 72 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K001134 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 5 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 4 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 3 generations backK053118 Sterling Monorail Pta Balloon Dilatation Catheter, Model…Boston Scientific Corp · 2005
- 2 generations backK102482 Flash Pta Balloon Dilatation Catheter 5MM X 19MM X 135CM; Flash Pta…Ostial Corporation · 2011
- 1 generation backK120738 Flash Pta Balloon Dilatation Catheter-4.0X14MMX135CMOstial Corporation · 2012
- This deviceK121175 Flash Pta Ballon Dilatation Catheter-5MM X 19MM X 135CMOstial Corporation · 2012
- Descendant · cites it directly · 2 of its ownK122379 Flash Pta Balloon Dilatation Catheter - 4MM X 14MM X 135CM, Flash…Ostial Corporation · 2012 · Recalled
- Descendant · cites it directly · 1 of its ownK133861 Flash Ostial System Otw-7.0MMX17MMX135CM, Flash Ostial System…Ostial Corporation · 2014
- Descendant · 2 generations on · 0 of its ownK150946 FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System…Ostial Corporation · 2015
Most influential descendants
Showing 3 of 3 · See all- K122379Flash Pta Balloon Dilatation Catheter - 4MM X 14MM X 135CM, Flash Pta Balloon Dilatation…Ostial Corporation · 2012 · cites it directly2descendants
- K133861Flash Ostial System Otw-7.0MMX17MMX135CM, Flash Ostial System Otw-7.0MMX17MMX80CMOstial Corporation · 2014 · cites it directly1descendant
- K150946FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x…Ostial Corporation · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −5 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −4 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −3 | K053118 | Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −2 | K102482 | Flash Pta Balloon Dilatation Catheter 5MM X 19MM X 135CM; Flash Pta Balloon… | Ostial Corporation | 2011 | — |
| −1 | K120738 | Flash Pta Balloon Dilatation Catheter-4.0X14MMX135CM | Ostial Corporation | 2012 | — |
| 0 (this device) | K121175 | Flash Pta Ballon Dilatation Catheter-5MM X 19MM X 135CM | Ostial Corporation | 2012 | — |
| +1 | K122379 | Flash Pta Balloon Dilatation Catheter - 4MM X 14MM X 135CM, Flash Pta Balloon… | Ostial Corporation | 2012 | 1 |
| +1 | K133861 | Flash Ostial System Otw-7.0MMX17MMX135CM, Flash Ostial System… | Ostial Corporation | 2014 | — |
| +2 | K150946 | FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x… | Ostial Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 LIT? 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 LIT device
- #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 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 |
|---|---|---|---|
| * | K053118 | Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-XxxxxxSummary page 1…uct Code LIT) C. Predicate Device Name(s) Primary Predicate: Trade Name(s): Sterling PTA Balloon Dilation Catheter, K(053118 Classification Name: Catheter, Percutaneous… | 2005 |
| * | K120738 | Flash Pta Balloon Dilatation Catheter-4.0X14MMX135CMSummary page 1…(21 CFR 870.1250, Product Code DQY) Secondary Predicate: Trade Name(s): Flash PTA Balloon Dilatation Catheter, K120738 Classification Name: Catheter, Angioplasty, Peripheral, Transluminal… | 2012 |
What descends from it? (3)
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K122379 (Ostial Corporation, 2012) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K053118.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LIT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LIT
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIT
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LIT
2,073in 2025
MAUDE reports naming product code LIT, 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 | 6 | 64 | 0 | 577 |
| 2008 | 8 | 53 | 0 | 513 |
| 2009 | 7 | 29 | 2 | 623 |
| 2010 | 13 | 78 | 1 | 809 |
| 2011 | 10 | 82 | 0 | 857 |
| 2012 | 19 | 29 | 0 | 1,277 |
| 2013 | 14 | 79 | 2 (2) | 1,242 |
| 2014 | 12 | 90 | 3 | 1,178 |
| 2015 | 19 | 112 | 0 | 1,279 |
| 2016 | 11 | 116 | 1 | 1,529 |
| 2017 | 9 | 57 | 0 | 2,081 |
| 2018 | 6 | 118 | 2 | 2,188 |
| 2019 | 4 | 40 | 3 | 2,405 |
| 2020 | 9 | 125 | 0 | 2,443 |
| 2021 | 4 | 61 | 1 | 2,492 |
| 2022 | 8 | 122 | 0 | 2,155 |
| 2023 | 6 | 167 | 0 | 1,807 |
| 2024 | 6 | 43 | 2 | 1,913 |
| 2025 | 3 | 90 | 1 | 2,073 |
| 2026 | 4 | 205 | 0 | — |
What is it indicated for?
The Flash PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121175: Flash Pta Ballon Dilatation Catheter-5MM X 19MM 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/K121175
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