510(k) · Cleared
ClearedMedcomp Vascu-Picc with Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcomp ( Medical Components) · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Oct 22, 2013 as substantially equivalent to K121094 (Medical Components, Inc., 2012) and 1 other predicate after a 204-day review. Its family tree reaches back 9 generations to 2000. 2 of the 30 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 22, 2013
- Review
- 204 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K001901 (2000). 29 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet. 2 of the 30 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK053501 PowerpiccBard Access Systems, Inc. · 2006
- 2 generations backK063848 Powergroshong Picc CatheterC.R. Bard, Inc. · 2007
- 1 generation backK072230 Powerpicc SoloC.R. Bard, Inc. · 2007 · Recalled
- This deviceK130897 Medcomp Vascu-Picc with ValveMedcomp ( Medical Components) · 2013
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 4 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 3 generations backK053501 PowerpiccBard Access Systems, Inc. · 2006
- 2 generations backK063848 Powergroshong Picc CatheterC.R. Bard, Inc. · 2007
- 1 generation backK072230 Powerpicc SoloC.R. Bard, Inc. · 2007 · Recalled
- This deviceK130897 Medcomp Vascu-Picc with ValveMedcomp ( Medical Components) · 2013
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −4 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −3 | K053501 | Powerpicc | Bard Access Systems, Inc. | 2006 | — |
| −2 | K063848 | Powergroshong Picc Catheter | C.R. Bard, Inc. | 2007 | — |
| −1 | K072230 | Powerpicc Solo | C.R. Bard, Inc. | 2007 | 4 |
| 0 (this device) | K130897 | Medcomp Vascu-Picc with Valve | Medcomp ( Medical Components) | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2007 | 1 | 0 |
| 2012 | 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.
2 devices in this family have a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K121094 | Medcomp Vascu-Picc & Midline CathetersSummary page 1…ction: 880.5970 Class: 1 C. Predicate Devices: K121094 Medeomp, Vascu-PICC' and Midline Catheters, class 11880.5970… | 2012 |
| * | K072230 | Powerpicc SoloSummary page 1…Midline Catheters, class 11880.5970 K072230 Bard Access Systems, Inc., PowerPlCC SOLOTh, clas 11880.5970… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 5 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 14 of the 29 ancestors have a recall of any class; 2 have a Class I recall.
- 3 other devices also cite its predicate K121094.
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. 2013, 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 Peripherally Inserted Central Vein Access Catheters with valve technology are designed for Long or Short-term peripheral access to the central venous system for intravenous therapy and blood sampling, and allows for central venous pressure monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130897 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130897: Medcomp Vascu-Picc with Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130897
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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