510(k) · Cleared
Recalled · 2008Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D
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 Mar 17, 2006 as substantially equivalent to K033389 (C.R. Bard, Inc., 2004) and 1 other predicate after a 105-day review. Its family tree reaches back 6 generations to 2000. 43 later devices descend from it. It has been recalled once.
- Decided
- Mar 17, 2006
- Review
- 105 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K001901 (2000). 8 ancestors in all, the oldest K830256 (1983). 43 later devices descend from it, 7 citing it directly.
- Root · 6 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 4 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 3 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 2 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 1 generation backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- This deviceK053345 Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6DMedcomp · 2006
- Descendant · cites it directly · 31 of its ownK081904 Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full…Medcomp · 2008 · Recalled
- Descendant · cites it directly · 29 of its ownK091953 Pro-PiccMedcomp · 2009
- Descendant · cites it directly · 9 of its ownK072391 PFM PiccPfm Medical, Inc. · 2007
- Descendant · 2 generations on · 8 of its ownK141151 CT MidlineMedcomp (Medical Components, Inc.) · 2014
- Descendant · cites it directly · 8 of its ownK093309 Pro-Line CT (Basic Tray) Model MR28036101Medcomp ( Medical Components) · 2009
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K081904Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)Medcomp · 2008 · cites it directly31descendants
- K091953Pro-PiccMedcomp · 2009 · cites it directly29descendants
- K072391PFM PiccPfm Medical, Inc. · 2007 · cites it directly9descendants
- K141151CT MidlineMedcomp (Medical Components, Inc.) · 2014 · 2 generations on8descendants
- K093309Pro-Line CT (Basic Tray) Model MR28036101Medcomp ( Medical Components) · 2009 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −5 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −4 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −3 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −2 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −1 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| 0 (this device) | K053345 | Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D | Medcomp | 2006 | — |
| +1 | K081904 | Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray) | Medcomp | 2008 | 2 |
| +1 | K091953 | Pro-Picc | Medcomp | 2009 | — |
| +1 | K072391 | PFM Picc | Pfm Medical, Inc. | 2007 | — |
| +2 | K141151 | CT Midline | Medcomp (Medical Components, Inc.) | 2014 | — |
| +1 | K093309 | Pro-Line CT (Basic Tray) Model MR28036101 | Medcomp ( Medical Components) | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K033389 | Powerpicc Catheters, Models 3175155, 3175135Summary page 1…: LJS C.F.R. Section: 880.5970 Class II C. Predicate Device: C.R. Bard, Inc. K033389 PowerPICCTM Catheters and C.R… | 2004 |
| * | K051417 | 6 FR FL Powerhohn and Powerline CatheterSummary page 1…C.R. Bard, Inc. K033389 PowerPICCTM Catheters and C.R. Bard, Inc. K051417 6Fr DL PowerHohnTM and PowerLineTM Catheter D. Device Description: The… | 2005 |
What descends from it? (43)
See all 437 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081904 | Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray) | 2008 | 31 |
| K091953 | Pro-Picc | 2009 | 29 |
| K072391 | PFM Picc | 2007 | 9 |
| K093309 | Pro-Line CT (Basic Tray) Model MR28036101 | 2009 | 8 |
| K110627 | Nexsite 9FR Dual Lumen Critical Care Central Venous Catheter | 2011 | 5 |
| K072509 | Pro-Picc, Basic Tray; Long Wire Tray; Basic Nursing Tray; Full Nursing Tray | 2007 | 0 |
| K071361 | R4 Vascular Inc. Pegasus CT Picc, Model 500005-001,002, 004, 005, 500004-001, 002,004,005 | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 11, 2008 | Not classified | Z-1910-2008 | Mixed-up of materials/components | kit contains incorrect component |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 5 of the 8 ancestors have a recall of any class.
- Of its descendants, K081904 (Medcomp, 2008) has gone furthest, with 31 descendants of its own.
- 10 other devices also cite its predicate K033389.
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 PRO-LINE Tm CT Power Injectable CVC is indicated for short or long term access to the central venous system. It is designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PRO-LINE Tm CT Power Injectable CVC may not exceed 300 psi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053345 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053345: Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053345
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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