510(k) · Cleared
ClearedPro-Picc
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 Sep 16, 2009 as substantially equivalent to K053345 (Medcomp, 2006) and 2 other predicates after a 77-day review. Its family tree reaches back 8 generations to 2000. 2 of the 54 devices in its family, counting itself, have a Class I recall. 29 later devices descend from it.
- Decided
- Sep 16, 2009
- Review
- 77 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K001901 (2000). 24 ancestors in all, the oldest K830256 (1983). 29 later devices descend from it, 8 citing it directly. 2 of the 54 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 6 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 5 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 4 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 3 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 2 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 1 generation backK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
- This deviceK091953 Pro-PiccMedcomp · 2009
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 6 of its ownK101329 Synergy CT PiccHealth Line International Corporation · 2010
- Descendant · 2 generations on · 5 of its ownK153393 PowerMidline CatheterC.R. Bard, Inc. · 2016 · Recalled
- Descendant · cites it directly · 3 of its ownK113487 Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc. · 2012
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 29 · See all- K141151CT MidlineMedcomp (Medical Components, Inc.) · 2014 · cites it directly8descendants
- K093309Pro-Line CT (Basic Tray) Model MR28036101Medcomp ( Medical Components) · 2009 · cites it directly8descendants
- K101329Synergy CT PiccHealth Line International Corporation · 2010 · 2 generations on6descendants
- K153393PowerMidline CatheterC.R. Bard, Inc. · 2016 · 2 generations on5descendants
- K113487Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc. · 2012 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −7 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −6 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −5 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −4 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −3 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −2 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −1 | K070996 | 4 FR Single Lumen (SL) Powerpicc Catheter | C.R. Bard, Inc. | 2007 | — |
| 0 (this device) | K091953 | Pro-Picc | Medcomp | 2009 | — |
| +1 | K141151 | CT Midline | Medcomp (Medical Components, Inc.) | 2014 | — |
| +1 | K093309 | Pro-Line CT (Basic Tray) Model MR28036101 | Medcomp ( Medical Components) | 2009 | — |
| +2 | K101329 | Synergy CT Picc | Health Line International Corporation | 2010 | — |
| +2 | K153393 | PowerMidline Catheter | C.R. Bard, Inc. | 2016 | 1 |
| +1 | K113487 | Hemo-Cath 10F, Hemo-Cath 12.5F | Medical Components, Inc. | 2012 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 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.
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? (3)
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…C.F.R. Section:- 880.5970 Class: 1U 'C.'i."' PredicateDevices:. K053345 Medcomp, PRO-LINE® CT Pressure, Injectable CVC, class ii 880.5970… | 2006 |
| * | K081904 | Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)Summary page 1…p, PRO-LINE® CT Pressure, Injectable CVC, class ii 880.5970 K081904.Medcomp, PRO-PICC® CT, -lass I 880.5970" K070996 Bard Acces's Syst.ems,, I… | 2008 |
| * | K070996 | 4 FR Single Lumen (SL) Powerpicc CatheterSummary page 1…i 880.5970 K081904.Medcomp, PRO-PICC® CT, -lass I 880.5970" K070996 Bard Acces's Syst.ems,, Inc., 4Fr SL PowerPICC®, class i88b.5970… | 2007 |
What descends from it? (29)
See all 298 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 · 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 9 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 12 of the 24 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K141151 (Medcomp (Medical Components, Inc.), 2014) has gone furthest, with 8 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 PRO-PICC® catheter is indicated for short term or long term peripheral access to the central-venous system for intravenous therapy and power injection of contrast media and allows for central venous pressure monitoring when a 20gauge or larger lumen is used. For blood sampling, infusion or therapies use a 4F or larger catheter. 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/K091953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091953: Pro-Picc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091953
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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