510(k) · Cleared
ClearedArrow Gpscath Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hotspur Technologies · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Jun 20, 2013 as substantially equivalent to K113769 (Hotspur Technologies, 2012) after a 121-day review. Its family tree reaches back 4 generations to 2002. 3 later devices descend from it.
- Decided
- Jun 20, 2013
- Review
- 121 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K014212 (2002). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK014212 Bard Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2002
- 3 generations backK073472 Vaccess Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled
- 2 generations backK101047 Pta-Duo Pta Balloon CatheterHotspur Technologies · 2010
- 1 generation backK113769 Gpscath Ballon Dilatation CatheterHotspur Technologies · 2012
- This deviceK130397 Arrow Gpscath Balloon Dilatation CatheterHotspur Technologies · 2013
- Descendant · cites it directly · 2 of its ownK151678 Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK163231 Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd. · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK170635 Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd. · 2017
Most influential descendants
Showing 3 of 3 · See all- K151678Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd. · 2015 · cites it directly2descendants
- K163231Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd. · 2017 · 2 generations on1descendant
- K170635Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K014212 | Bard Conquest Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2002 | — |
| −3 | K073472 | Vaccess Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2008 | 1 |
| −2 | K101047 | Pta-Duo Pta Balloon Catheter | Hotspur Technologies | 2010 | — |
| −1 | K113769 | Gpscath Ballon Dilatation Catheter | Hotspur Technologies | 2012 | — |
| 0 (this device) | K130397 | Arrow Gpscath Balloon Dilatation Catheter | Hotspur Technologies | 2013 | — |
| +1 | K151678 | Chameleon PTA Balloon Catheter | Av Medical Technologies, Ltd. | 2015 | — |
| +2 | K163231 | Chameleon PTA Balloon Catheter | Av Medical Technologies, Ltd. | 2017 | 2 |
| +3 | K170635 | Chameleon PTA Balloon Catheter | Av Medical Technologies, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 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 |
|---|---|---|---|
| * | K113769 | Gpscath Ballon Dilatation CatheterSummary page 1…ty, Peripheral, Transluminal/Percutaneous Catheter (21 CFR 870.1250, Product Code LIT) C. Predicate Device Name(s) Trade Name(s): GPSCath Balloon Dilatation Catheter, #K113769 D. Reference Device Name(s) Trade Name(s): GPSCath Balloon Dilatation Catheter (Cleared under the name PTA-Duo PTA Balloon Cathe… | 2012 |
| † | K101047 | Pta-Duo Pta Balloon Catheter | 2010 |
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 |
|---|---|---|---|
| K151678 | Chameleon PTA Balloon Catheter | 2015 | 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 11 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K151678 (Av Medical Technologies, Ltd., 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Arrow GPSCath Balloon Dilatation Catheter is indicated for use in
percutaneous transluminal angioplasty of the femoral, iliac, and renal arteries and
for the treatment of obstructive lesions of native or synthetic arteriovenous
dialysis fistulae. This catheter is not for use in coronary arteries.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130397 · printed Nov 3, 2026
Cite this page
510(k) Report. “K130397: Arrow Gpscath Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K130397
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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