510(k) · Cleared
Cleared018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creagh Medical, Ltd. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Apr 19, 2018 as substantially equivalent to K132430 (Boston Scientific Corp, 2013) after a 107-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Apr 19, 2018
- Review
- 107 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001134 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 4 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 3 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 2 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 1 generation backK132430 Sterling Over-the-Wire (Otw) Pta Balloon Dilatation CatheterBoston Scientific Corp · 2013
- This deviceK180007 018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterCreagh Medical, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK242419 018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterCreagh Medical Ltd. Dba Surmodics, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K242419018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterCreagh Medical Ltd. Dba Surmodics, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −4 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −3 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −2 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −1 | K132430 | Sterling Over-the-Wire (Otw) Pta Balloon Dilatation Catheter | Boston Scientific Corp | 2013 | — |
| 0 (this device) | K180007 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Creagh Medical, Ltd. | 2018 | — |
| +1 | K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | Creagh Medical Ltd. Dba Surmodics, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K132430 | Sterling Over-the-Wire (Otw) Pta Balloon Dilatation CatheterSummary page 4…I Product Code: LIT Predicate Device: SterlingTM Over-the-WireTM (OTW) PTA Balloon Dilatation Catheter 510(k)#: K132430 K180007 Page |2 Device De… | 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 |
|---|---|---|---|
| K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | 2024 | 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 18 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K242419 (Creagh Medical Ltd. Dba Surmodics, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K132430.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, 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/K180007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180007: 018 Hydrophilic Coated OTW 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/K180007
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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