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, 2025 as substantially equivalent to K241040 (Natec Medical, Ltd., 2024) after a 178-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- Dec 18, 2025
- Review
- 178 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K933483 (1993). 38 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK933483 Opti-Plast 5F Pta CathetersVas-Cath, Inc. · 1993
- 6 generations between
- 3 generations backK141985 True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc. · 2014
- 2 generations backK212588 Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation…C.R. Bard, Inc. · 2022
- 1 generation backK241040 Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2024
- This deviceK251915 Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2025
Show all 10 generations
- Root · 10 generations backK933483 Opti-Plast 5F Pta CathetersVas-Cath, Inc. · 1993
- 9 generations backK973013 Opti-Plast (Centurion) 5.5F Angioplasty CatheterVas-Cath, Inc. · 1998
- 8 generations backK040243 Bard Atlas Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2004
- 7 generations backK052236 Bard Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2005
- 6 generations backK120971 Atlas Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2012
- 5 generations backK122984 Atlas Gold Pta Dilatation CatheterC.R. Bard, Inc. · 2012
- 4 generations backK131002 Vida PTV Dilataton CatheterC.R. Bard, Inc. · 2013
- 3 generations backK141985 True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc. · 2014
- 2 generations backK212588 Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation…C.R. Bard, Inc. · 2022
- 1 generation backK241040 Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2024
- This deviceK251915 Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K933483 | Opti-Plast 5F Pta Catheters | Vas-Cath, Inc. | 1993 | — |
| −9 | K973013 | Opti-Plast (Centurion) 5.5F Angioplasty Catheter | Vas-Cath, Inc. | 1998 | — |
| −8 | K040243 | Bard Atlas Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2004 | — |
| −7 | K052236 | Bard Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2005 | — |
| −6 | K120971 | Atlas Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2012 | — |
| −5 | K122984 | Atlas Gold Pta Dilatation Catheter | C.R. Bard, Inc. | 2012 | — |
| −4 | K131002 | Vida PTV Dilataton Catheter | C.R. Bard, Inc. | 2013 | — |
| −3 | K141985 | True BA V Balloon Valvuloplasty Catheter | C.R. Bard, Inc. | 2014 | — |
| −2 | K212588 | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida… | C.R. Bard, Inc. | 2022 | — |
| −1 | K241040 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical, Ltd. | 2024 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K241040 | Amethyst HP PTA OTW 0.035 CatheterSummary page 5…Number: 21 CFR 870.1250 Product Code: LIT Device Class: Class II Predicate Devices: Amethyst HP PTA OTW 0.035” Catheter – K241040 Device Description: The Amethyst HP PTA OTW 0.035” catheter is a balloon catheter consisting of an over the wire catheter with a… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 6 of the 38 ancestors have a recall of any class.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 as stated in the FDA summary.
https://510kreport.com/device/K251915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251915: 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/K251915
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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