510(k) · Cleared
ClearedCT Midline
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcomp (Medical Components, Inc.) · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Jul 8, 2014 as substantially equivalent to K121094 (Medical Components, Inc., 2012) and 1 other predicate after a 64-day review. Its family tree reaches back 9 generations to 2000. 2 of the 35 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Jul 8, 2014
- Review
- 64 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K001901 (2000). 26 ancestors in all, the oldest K830256 (1983). 8 later devices descend from it, 3 citing it directly. 2 of the 35 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 backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
- 1 generation backK091953 Pro-PiccMedcomp · 2009
- This deviceK141151 CT MidlineMedcomp (Medical Components, Inc.) · 2014
- Descendant · cites it directly · 5 of its ownK153393 PowerMidline CatheterC.R. Bard, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK173114 primeMidline CathetersPfm Medical, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK162900 PowerMidline CatheterC.R. Bard, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 0 of its ownK213203 Provena (TM) Midline CatheterC.R. Bard, Inc. · 2022 · Recalled
- Descendant · 3 generations on · 0 of its ownK192802 primeMidline CathetersPfm Medical, Inc. · 2019
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 backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 4 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
- 1 generation backK091953 Pro-PiccMedcomp · 2009
- This deviceK141151 CT MidlineMedcomp (Medical Components, Inc.) · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K153393PowerMidline CatheterC.R. Bard, Inc. · 2016 · cites it directly5descendants
- K173114primeMidline CathetersPfm Medical, Inc. · 2018 · 2 generations on1descendant
- K162900PowerMidline CatheterC.R. Bard, Inc. · 2016 · 2 generations on1descendant
- K213203Provena (TM) Midline CatheterC.R. Bard, Inc. · 2022 · 3 generations on0descendants
- K192802primeMidline CathetersPfm Medical, Inc. · 2019 · 3 generations on0descendants
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 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −4 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −3 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −2 | K070996 | 4 FR Single Lumen (SL) Powerpicc Catheter | C.R. Bard, Inc. | 2007 | — |
| −1 | K091953 | Pro-Picc | Medcomp | 2009 | — |
| 0 (this device) | K141151 | CT Midline | Medcomp (Medical Components, Inc.) | 2014 | — |
| +1 | K153393 | PowerMidline Catheter | C.R. Bard, Inc. | 2016 | 1 |
| +2 | K173114 | primeMidline Catheters | Pfm Medical, Inc. | 2018 | — |
| +2 | K162900 | PowerMidline Catheter | C.R. Bard, Inc. | 2016 | 3 |
| +3 | K213203 | Provena (TM) Midline Catheter | C.R. Bard, Inc. | 2022 | 1 |
| +3 | K192802 | primeMidline Catheters | Pfm Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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…Class: I1.L S Predicate Devices: Primiary: K 121094. Midline, concurrence date June 6. 2012, Class 11. 21 CER 880.970 K091953, Pro-PICC CT, concurrenc… | 2012 |
| * | K091953 | Pro-PiccSummary page 1…Primiary: K 121094. Midline, concurrence date June 6. 2012, Class 11. 21 CER 880.970 K091953, Pro-PICC CT, concurrence date September 16. 2009, Class 11 21 CFR 880.5970 Device Description:… | 2009 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 5 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 · 6 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 12 of the 26 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K153393 (C.R. Bard, Inc., 2016) has gone furthest, with 5 descendants of its own.
- 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. 2014, 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 CT Midlines are indicated for Short-Term peripheral access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141151: CT Midline.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141151
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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