510(k) · Cleared
ClearedMedcomp Vascu-Picc & Midline Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Components, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Jun 6, 2012 after a 57-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.
- Decided
- Jun 6, 2012
- Review
- 57 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 4 citing it directly.
- This deviceK121094 Medcomp Vascu-Picc & Midline CathetersMedical Components, Inc. · 2012
- Descendant · cites it directly · 8 of its ownK141151 CT MidlineMedcomp (Medical Components, Inc.) · 2014
- Descendant · 2 generations on · 5 of its ownK153393 PowerMidline CatheterC.R. Bard, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 1 of its ownK173114 primeMidline CathetersPfm Medical, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK162900 PowerMidline CatheterC.R. Bard, Inc. · 2016 · Recalled
- Descendant · 4 generations on · 0 of its ownK213203 Provena (TM) Midline CatheterC.R. Bard, Inc. · 2022 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K141151CT MidlineMedcomp (Medical Components, Inc.) · 2014 · cites it directly8descendants
- K153393PowerMidline CatheterC.R. Bard, Inc. · 2016 · 2 generations on5descendants
- K173114primeMidline CathetersPfm Medical, Inc. · 2018 · 3 generations on1descendant
- K162900PowerMidline CatheterC.R. Bard, Inc. · 2016 · 3 generations on1descendant
- K213203Provena (TM) Midline CatheterC.R. Bard, Inc. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K121094 | Medcomp Vascu-Picc & Midline Catheters | Medical Components, Inc. | 2012 | — |
| +1 | K141151 | CT Midline | Medcomp (Medical Components, Inc.) | 2014 | — |
| +2 | K153393 | PowerMidline Catheter | C.R. Bard, Inc. | 2016 | 1 |
| +3 | K173114 | primeMidline Catheters | Pfm Medical, Inc. | 2018 | — |
| +3 | K162900 | PowerMidline Catheter | C.R. Bard, Inc. | 2016 | 3 |
| +4 | K213203 | Provena (TM) Midline Catheter | C.R. Bard, Inc. | 2022 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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? (12)
See all 124 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, K141151 (Medcomp (Medical Components, Inc.), 2014) has gone furthest, with 8 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. 2012, 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 are designed for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling, For central venous pressure monitoring (CVP), it is recommended that catheter lumen of 20 gauge or larger be used.
The Mdline catheters are indicated for shaft or long term peripheral access to the peripheral veious system for selected intravenous therapies and blood sampling. (See Confraindications). For blood therapy it is recommended that a 4F7rench or larger catheter be used.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K121094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121094: Medcomp Vascu-Picc & Midline Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121094
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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