510(k) · Cleared
Cleared014 Hydrophilic Coated PTA Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creagh Medical · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Sep 8, 2017 as substantially equivalent to K102645 (Creagh Medical, Ltd., 2010) after a 133-day review. Its family tree reaches back 4 generations to 2004. 2 later devices descend from it.
- Decided
- Sep 8, 2017
- Review
- 133 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042537 (2004). 9 ancestors in all, the oldest K014212 (2002). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK042537 Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
- 3 generations backK072947 Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta)…ClearStream Technologies, Ltd. · 2008
- 2 generations backK083919 Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 2009 · Recalled
- 1 generation backK102645 Willow/Elm Pta Balloon Dilatation CatheterCreagh Medical, Ltd. · 2010
- This deviceK171251 014 Hydrophilic Coated PTA Balloon Dilatation CatheterCreagh Medical · 2017
- Descendant · cites it directly · 1 of its ownK200700 Surmodics Sublime Radial Access 014 RX PTA (Percutaneous…Creagh Medical, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK211044 Sublime Radial Access 018 RX Dilatation CatheterCreagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, · 2021
Most influential descendants
Showing 2 of 2 · See all- K200700Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty)…Creagh Medical, Ltd. · 2020 · cites it directly1descendant
- K211044Sublime Radial Access 018 RX Dilatation CatheterCreagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042537 | Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model… | Invatec Innovative Technologies | 2004 | — |
| −3 | K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters | ClearStream Technologies, Ltd. | 2008 | — |
| −2 | K083919 | Amphirion Deep 0.014 Otw Pta Balloon Catheter | Invatec Innovative Technologies, S.R.L. | 2009 | 1 |
| −1 | K102645 | Willow/Elm Pta Balloon Dilatation Catheter | Creagh Medical, Ltd. | 2010 | — |
| 0 (this device) | K171251 | 014 Hydrophilic Coated PTA Balloon Dilatation Catheter | Creagh Medical | 2017 | — |
| +1 | K200700 | Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal… | Creagh Medical, Ltd. | 2020 | — |
| +2 | K211044 | Sublime Radial Access 018 RX Dilatation Catheter | Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K102645 | Willow/Elm Pta Balloon Dilatation CatheterSummary page 4…Cardiovascular The 014 Hydrophilic Coated PTA Balloon Dilatation Catheter is substantially equivalent to the previously-cleared WILLOW PTA Balloon Dilatation Catheter (K102645). The previously cleared AMPHIRION DEEP 0.014” OTW PTA Balloon Dilatation Catheter (K050073, K052791, K042624, K083919) is also c… | 2010 |
| † | K050073 | Modification to Amphirion Deep 0.014 Otw Pta Balloon Catheter | 2005 |
| † | K052791 | Modification to: Amphirion Deep 0.014 Otw Pta Balloon Catheter | 2005 |
| † | K042624 | Amphirion Deep 0.014 Otw Pta Balloon Catheter | 2005 |
| † | K083919 | Amphirion Deep 0.014 Otw Pta Balloon Catheter | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200700 | Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty)… | 2020 | 1 |
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 13 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 5 of the 9 ancestors have a recall of any class.
- Of its descendants, K200700 (Creagh Medical, Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K102645.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 014 Hydrophilic Coated PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171251: 014 Hydrophilic Coated PTA Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171251
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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