510(k) · Cleared
ClearedVygon 2 FR Epicutaneo Pur-Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vygon Corp. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Aug 3, 2000 after a 325-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Aug 3, 2000
- Review
- 325 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK993052 Vygon 2 FR Epicutaneo Pur-CatheterVygon Corp. · 2000
- Descendant · cites it directly · 5 of its ownK061986 1.9F X 20 CM Vascu-Picc, Models VP1.9S20 and VP1.9S50Medcomp · 2006
- Descendant · 2 generations on · 4 of its ownK091466 1.9F X 20CM Vascu-Picc, 1.9F X 50CM Vascu-Picc, Model Vpi.9S20…Medcomp · 2009
- Descendant · 3 generations on · 3 of its ownK102966 2.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-PiccMedcomp · 2010
- Descendant · 4 generations on · 2 of its ownK130034 Uni-PiccHealth Line International Corporation · 2013
- Descendant · 5 generations on · 1 of its ownK140270 Nexus Midline CT CatheterHealth Line International Corporation · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K0619861.9F X 20 CM Vascu-Picc, Models VP1.9S20 and VP1.9S50Medcomp · 2006 · cites it directly5descendants
- K0914661.9F X 20CM Vascu-Picc, 1.9F X 50CM Vascu-Picc, Model Vpi.9S20, Vpi.9S50Medcomp · 2009 · 2 generations on4descendants
- K1029662.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-PiccMedcomp · 2010 · 3 generations on3descendants
- K130034Uni-PiccHealth Line International Corporation · 2013 · 4 generations on2descendants
- K140270Nexus Midline CT CatheterHealth Line International Corporation · 2014 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993052 | Vygon 2 FR Epicutaneo Pur-Catheter | Vygon Corp. | 2000 | — |
| +1 | K061986 | 1.9F X 20 CM Vascu-Picc, Models VP1.9S20 and VP1.9S50 | Medcomp | 2006 | — |
| +2 | K091466 | 1.9F X 20CM Vascu-Picc, 1.9F X 50CM Vascu-Picc, Model Vpi.9S20, Vpi.9S50 | Medcomp | 2009 | — |
| +3 | K102966 | 2.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-Picc | Medcomp | 2010 | — |
| +4 | K130034 | Uni-Picc | Health Line International Corporation | 2013 | — |
| +5 | K140270 | Nexus Midline CT Catheter | Health Line International Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LJS? 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 LJS device
- #1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061986 | 1.9F X 20 CM Vascu-Picc, Models VP1.9S20 and VP1.9S50 | 2006 | 5 |
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?
- Of its descendants, K061986 (Medcomp, 2006) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LJS devicesLJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LJS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJS
5in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · LJS
4,372in 2025
MAUDE reports naming product code LJS, 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 | 14 | 92 | 0 | 392 |
| 2008 | 4 | 97 | 1 | 369 |
| 2009 | 16 | 70 | 1 | 379 |
| 2010 | 9 | 114 | 12 | 495 |
| 2011 | 6 | 55 | 4 | 696 |
| 2012 | 14 | 77 | 40 | 564 |
| 2013 | 14 | 31 | 0 | 680 |
| 2014 | 8 | 47 | 15 | 842 |
| 2015 | 7 | 71 | 2 | 1,306 |
| 2016 | 9 | 128 | 18 | 1,123 |
| 2017 | 7 | 101 | 9 | 2,100 |
| 2018 | 10 | 148 | 3 | 2,324 |
| 2019 | 0 | — | 0 | 2,052 |
| 2020 | 2 | — | 0 | 2,539 |
| 2021 | 3 | 284 | 1 | 3,084 |
| 2022 | 3 | 177 | 0 | 3,256 |
| 2023 | 4 | 47 | 5 (2) | 2,799 |
| 2024 | 1 | — | 0 | 4,243 |
| 2025 | 8 | 171 | 0 | 4,372 |
| 2026 | 2 | — | 8 (1) | — |
What is it indicated for?
The Vygon 2 FR Epicutaheo PUR Catheter is intended for use in neonates who require long term L.V. therapy. It may be used to administer hyperalimentation, antibiotics, chemotherapy, drugs for pain management or intravenous fluids.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993052: Vygon 2 FR Epicutaneo Pur-Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993052
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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