510(k) · Cleared
ClearedAmethyst HP PTA OTW 0.035 Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natec Medical, Ltd. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Dec 18, 2024 as substantially equivalent to K212588 (C.R. Bard, Inc., 2022) and 1 other predicate after a 246-day review. Its family tree reaches back 9 generations to 1993. 1 later device descends from it.
- Decided
- Dec 18, 2024
- Review
- 246 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K933483 (1993). 37 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK933483 Opti-Plast 5F Pta CathetersVas-Cath, Inc. · 1993
- 5 generations between
- 3 generations backK131002 Vida PTV Dilataton CatheterC.R. Bard, Inc. · 2013
- 2 generations backK141985 True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc. · 2014
- 1 generation backK212588 Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation…C.R. Bard, Inc. · 2022
- This deviceK241040 Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK251915 Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK933483 Opti-Plast 5F Pta CathetersVas-Cath, Inc. · 1993
- 8 generations backK973013 Opti-Plast (Centurion) 5.5F Angioplasty CatheterVas-Cath, Inc. · 1998
- 7 generations backK040243 Bard Atlas Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2004
- 6 generations backK052236 Bard Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2005
- 5 generations backK120971 Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2012
- 4 generations backK122984 Atlas Gold Pta Dilatation CatheterC.R. Bard, Inc. · 2012
- 3 generations backK131002 Vida PTV Dilataton CatheterC.R. Bard, Inc. · 2013
- 2 generations backK141985 True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc. · 2014
- 1 generation backK212588 Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation…C.R. Bard, Inc. · 2022
- This deviceK241040 Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K933483 | Opti-Plast 5F Pta Catheters | Vas-Cath, Inc. | 1993 | — |
| −8 | K973013 | Opti-Plast (Centurion) 5.5F Angioplasty Catheter | Vas-Cath, Inc. | 1998 | — |
| −7 | K040243 | Bard Atlas Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2004 | — |
| −6 | K052236 | Bard Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2005 | — |
| −5 | K120971 | Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2012 | — |
| −4 | K122984 | Atlas Gold Pta Dilatation Catheter | C.R. Bard, Inc. | 2012 | — |
| −3 | K131002 | Vida PTV Dilataton Catheter | C.R. Bard, Inc. | 2013 | — |
| −2 | K141985 | True BA V Balloon Valvuloplasty Catheter | C.R. Bard, Inc. | 2014 | — |
| −1 | K212588 | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida… | C.R. Bard, Inc. | 2022 | — |
| 0 (this device) | K241040 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical, Ltd. | 2024 | — |
| +1 | K251915 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 K260416 ZYLOX Hippo PTA Balloon Dilatation Catheterscore 13.8 · 7 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 |
|---|---|---|---|
| * | K212588 | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV…Summary page 5…r: 21 CFR 870.1250 Product Code: LIT Device Class: Class II Predicate Devices: Conquest™ 40 PTA Dilatation Catheter - K212588/ K120660 Device Description: The Amethyst HP PTA OTW 0.035 catheter is a balloon catheter consisting of an over the wire cathete… | 2022 |
| * | K120660 | Conquest 40 Pta Dilatation CatheterSummary page 5…21 CFR 870.1250 Product Code: LIT Device Class: Class II Predicate Devices: Conquest™ 40 PTA Dilatation Catheter - K212588/ K120660 Device Description: The Amethyst HP PTA OTW 0.035 catheter is a balloon catheter consisting of an over the wire catheter with a… | 2012 |
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 |
|---|---|---|---|
| K251915 | Amethyst HP PTA OTW 0.035 Catheter | 2025 | 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 31 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 6 of the 37 ancestors have a recall of any class.
- Of its descendants, K251915 (Natec Medical, Ltd., 2025) has gone furthest, with 0 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. 2024, 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 Amethyst HP PTA OTW 0.035" catheter is indicated for:
- Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature including iliac, femoral, popliteal, tibial, peroneal, subclavian, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
- Post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature
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/K241040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241040: Amethyst HP PTA OTW 0.035 Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241040
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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