510(k) · Cleared
Cleared1.9F X 20CM Vascu-Picc, 1.9F X 50CM Vascu-Picc, Model Vpi.9S20, Vpi.9S50
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 Jun 17, 2009 as substantially equivalent to K061986 (Medcomp, 2006) after a 30-day review. Its family tree reaches back 2 generations to 2000. 4 later devices descend from it.
- Decided
- Jun 17, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K993052 (2000). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK993052 Vygon 2 FR Epicutaneo Pur-CatheterVygon Corp. · 2000
- 1 generation backK061986 1.9F X 20 CM Vascu-Picc, Models VP1.9S20 and VP1.9S50Medcomp · 2006
- This deviceK091466 1.9F X 20CM Vascu-Picc, 1.9F X 50CM Vascu-Picc, Model Vpi.9S20…Medcomp · 2009
- Descendant · cites it directly · 3 of its ownK102966 2.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-PiccMedcomp · 2010
- Descendant · 2 generations on · 2 of its ownK130034 Uni-PiccHealth Line International Corporation · 2013
- Descendant · 3 generations on · 1 of its ownK140270 Nexus Midline CT CatheterHealth Line International Corporation · 2014
- Descendant · 4 generations on · 0 of its ownK200263 Health Line CT Midline CatheterHealth Line International Corporation · 2020
Most influential descendants
Showing 4 of 4 · See all- K1029662.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-PiccMedcomp · 2010 · cites it directly3descendants
- K130034Uni-PiccHealth Line International Corporation · 2013 · 2 generations on2descendants
- K140270Nexus Midline CT CatheterHealth Line International Corporation · 2014 · 3 generations on1descendant
- K200263Health Line CT Midline CatheterHealth Line International Corporation · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K091466 | 1.9F X 20CM Vascu-Picc, 1.9F X 50CM Vascu-Picc, Model Vpi.9S20, Vpi.9S50 | Medcomp | 2009 | — |
| +1 | K102966 | 2.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-Picc | Medcomp | 2010 | — |
| +2 | K130034 | Uni-Picc | Health Line International Corporation | 2013 | — |
| +3 | K140270 | Nexus Midline CT Catheter | Health Line International Corporation | 2014 | — |
| +4 | K200263 | Health Line CT Midline Catheter | Health Line International Corporation | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 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 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061986 | 1.9F X 20 CM Vascu-Picc, Models VP1.9S20 and VP1.9S50Summary page 1…er then 30 Days CFR Reference: 21 CFR 880.5970, Class II Classification Panel: General Hospital Premarket Notification: K061 986, concurrence date August 15, 2006 Performance Standards: Performance standards have not been established by FDA. under section… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102966 | 2.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-Picc | 2010 | 3 |
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 9 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K102966 (Medcomp, 2010) 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. 2009, this device’s year, is highlighted.
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 1.9F Vascu-PICC® is a long term catheter intended for central venous access via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091466: 1.9F X 20CM Vascu-Picc, 1.9F X 50CM Vascu-Picc, Model Vpi.9S20, Vpi.9S50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091466
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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