510(k) · Cleared
ClearedPro-Line CT (Basic Tray) Model MR28036101
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 Nov 24, 2009 as substantially equivalent to K053345 (Medcomp, 2006) and 1 other predicate after a 33-day review. Its family tree reaches back 9 generations to 2000. 2 of the 34 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Nov 24, 2009
- Review
- 33 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K001901 (2000). 25 ancestors in all, the oldest K830256 (1983). 8 later devices descend from it, 2 citing it directly. 2 of the 34 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 deviceK093309 Pro-Line CT (Basic Tray) Model MR28036101Medcomp ( Medical Components) · 2009
- Descendant · cites it directly · 6 of its ownK101329 Synergy CT PiccHealth Line International Corporation · 2010
- Descendant · 2 generations on · 2 of its ownK130034 Uni-PiccHealth Line International Corporation · 2013
- Descendant · 2 generations on · 1 of its ownK140270 Nexus Midline CT CatheterHealth Line International Corporation · 2014
- Descendant · 2 generations on · 1 of its ownK113622 Orion II CT CVCHealth Line International Corporation (Hlic) · 2012
- Descendant · 3 generations on · 0 of its ownK200263 Health Line CT Midline CatheterHealth Line International Corporation · 2020
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 deviceK093309 Pro-Line CT (Basic Tray) Model MR28036101Medcomp ( Medical Components) · 2009
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- K101329Synergy CT PiccHealth Line International Corporation · 2010 · cites it directly6descendants
- K130034Uni-PiccHealth Line International Corporation · 2013 · 2 generations on2descendants
- K140270Nexus Midline CT CatheterHealth Line International Corporation · 2014 · 2 generations on1descendant
- K113622Orion II CT CVCHealth Line International Corporation (Hlic) · 2012 · 2 generations on1descendant
- K200263Health Line CT Midline CatheterHealth Line International Corporation · 2020 · 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) | K093309 | Pro-Line CT (Basic Tray) Model MR28036101 | Medcomp ( Medical Components) | 2009 | — |
| +1 | K101329 | Synergy CT Picc | Health Line International Corporation | 2010 | — |
| +2 | K130034 | Uni-Picc | Health Line International Corporation | 2013 | — |
| +2 | K140270 | Nexus Midline CT Catheter | Health Line International Corporation | 2014 | — |
| +2 | K113622 | Orion II CT CVC | Health Line International Corporation (Hlic) | 2012 | — |
| +3 | K200263 | Health Line CT Midline Catheter | Health Line International Corporation | 2020 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2019 | 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.
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 |
|---|---|---|---|
| * | K053345 | Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6DSummary page 1…0 Days CFR Reference: 21 CFR 880.5970, Class II Classification Panel: General Hospital Premarket Notification: K053345, concurrence date March 17, 2006 K091953, concurrence date September 16, 2009. Perform… | 2006 |
| * | K091953 | Pro-PiccSummary page 1…lassification Panel: General Hospital Premarket Notification: K053345, concurrence date March 17, 2006 K091953, concurrence date September 16, 2009. Performance Standards: Performance standards have not been established by FDA under sect… | 2009 |
What descends from it? (8)
2 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 9 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 12 of the 25 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K101329 (Health Line International Corporation, 2010) has gone furthest, with 6 descendants of its own.
- 6 other devices also cite its predicate K053345.
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 Medcomp PRO-LINETM 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-LINETM CT Power Injectable CVC may not exceed 300 psi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093309 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093309: Pro-Line CT (Basic Tray) Model MR28036101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093309
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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