510(k) · Cleared
ClearedEbony Pta 0.014 Peripheral Dilatation 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 9, 2011 as substantially equivalent to K083919 (Invatec Innovative Technologies, S.R.L., 2009) and 2 other predicates after a 101-day review. Its family tree reaches back 6 generations to 2000. 3 later devices descend from it.
- Decided
- Dec 9, 2011
- Review
- 101 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K001134 (2000). 19 ancestors in all, the oldest K971448 (1997). 3 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 5 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 4 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 3 generations backK053118 Sterling Monorail Pta Balloon Dilatation Catheter, Model…Boston Scientific Corp · 2005
- 2 generations backK063563 Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon…Cordis Europa, N.V. · 2007
- 1 generation backK071189 Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V. · 2007
- This deviceK112513 Ebony Pta 0.014 Peripheral Dilatation CatheterNatec Medical, Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK142459 Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK152230 Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK143041 Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over…Natec Medical, Ltd. · 2015
Most influential descendants
Showing 3 of 3 · See all- K142459Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd. · 2015 · cites it directly1descendant
- K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical · 2015 · cites it directly0descendants
- K143041Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire CatheterNatec Medical, Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −5 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −4 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −3 | K053118 | Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −2 | K063563 | Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation… | Cordis Europa, N.V. | 2007 | — |
| −1 | K071189 | Cordis Aviator Plus Pta Balloon Dilatation Catheter | Cordis Europa, N.V. | 2007 | — |
| 0 (this device) | K112513 | Ebony Pta 0.014 Peripheral Dilatation Catheter | Natec Medical, Ltd. | 2011 | — |
| +1 | K142459 | Ebony PTA 0.014 RX Peripheral Dilatation Catheter | Natec Medical, Ltd. | 2015 | — |
| +1 | K152230 | Ebony PTA .014 RX Pheripheral Dilatation Catheter | Natec Medical | 2015 | 1 |
| +1 | K143041 | Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire… | Natec Medical, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K083919 | Amphirion Deep 0.014 Otw Pta Balloon CatheterSummary page 1…ATE DEVICE 807.92(a)(3) Legally Marketed Equivalent Devices: * Invatec Amphirion Deep PTA 0.014" Balloon Catheter - K083919 " Cordis AVIATOR Plus PTA Balloon dilatation catheter - K071189 * Boston Ultra Soft SV PTA Dilatation Catheter-… | 2009 |
| * | K071189 | Cordis Aviator Plus Pta Balloon Dilatation CatheterSummary page 1…lly Marketed Equivalent Devices: * Invatec Amphirion Deep PTA 0.014" Balloon Catheter - K083919 " Cordis AVIATOR Plus PTA Balloon dilatation catheter - K071189 * Boston Ultra Soft SV PTA Dilatation Catheter- K050389 DEVICE DESCRIPTION 8… | 2007 |
| * | K050389 | Ultra-Soft SV Balloon Dilatation CatheterSummary page 1…p PTA 0.014" Balloon Catheter - K083919 " Cordis AVIATOR Plus PTA Balloon dilatation catheter - K071189 * Boston Ultra Soft SV PTA Dilatation Catheter- K050389 DEVICE DESCRIPTION 807.92(a)(4) The EbonyO PTA 0.014" Peripheral Dilatation Catheter… | 2005 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 19 ancestors have a recall of any class.
- Of its descendants, K142459 (Natec Medical, Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K083919.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Ebony 0.014" PTA Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, renal and carotid arteries.
This catheter is not for use in coronary or neuro-vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112513: Ebony Pta 0.014 Peripheral 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/K112513
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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