510(k) · Cleared
Cleared3F X 60 CM Single Lumen Silisone Vascu-Picc, 4F X 60CM Single Lumen Silicone Vascu-Picc, 5F X 60 CM Single Lumen Silicon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcomp · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Apr 11, 2003 after a 74-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 10 later devices descend from it.
- Decided
- Apr 11, 2003
- Review
- 74 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 1
10 later devices descend from it, 4 citing it directly.
- This deviceK030270 3F X 60 CM Single Lumen Silisone Vascu-Picc, 4F X 60CM Single Lumen…Medcomp · 2003
- Descendant · cites it directly · 3 of its ownK113487 Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK031689 Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2003
- Descendant · 2 generations on · 2 of its ownK041791 5.2F Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK233515 Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual…Nuwellis, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK130851 Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation · 2014
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K113487Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc. · 2012 · cites it directly3descendants
- K031689Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2003 · cites it directly3descendants
- K0417915.2F Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2004 · 2 generations on2descendants
- K233515Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended…Nuwellis, Inc. · 2023 · 2 generations on1descendant
- K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030270 | 3F X 60 CM Single Lumen Silisone Vascu-Picc, 4F X 60CM Single Lumen Silicone… | Medcomp | 2003 | — |
| +1 | K113487 | Hemo-Cath 10F, Hemo-Cath 12.5F | Medical Components, Inc. | 2012 | — |
| +1 | K031689 | Dual Lumen Extended Length Catheter (Delc) | Chf Solutions, Inc. | 2003 | — |
| +2 | K041791 | 5.2F Dual Lumen Extended Length Catheter (Delc) | Chf Solutions, Inc. | 2004 | — |
| +2 | K233515 | Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen… | Nuwellis, Inc. | 2023 | — |
| +2 | K130851 | Cascade Hemodialysis/Apheresis Catheter | Health Line International Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K013605 | Cook PICC Catheters Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (10)
4 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?
- Of its descendants, K113487 (Medical Components, Inc., 2012) has gone furthest, with 3 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 MEDCOMP SILICONE Vascu-PICC” CATHETERS ARE DESIGNED FOR LONG-TERM CENTRAL VENOUS CATHETERIZATION OR PROLONGED INTRAVENOUS ADMINISTRATION OF FLUIDS, MEDICATION, AND /OR WHEN NUTRITIONAL THERAPY IS PRESCRIBED.
THIS CATHETER MAY BE INSERTED VIA THE BASILIC OR CEPHALIC VEIN.
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/K030270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030270: 3F X 60 CM Single Lumen Silisone Vascu-Picc, 4F X 60CM Single Lumen Silicone Vascu-Picc, 5F X 60 CM Single Lumen Silicon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030270
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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