510(k) · Cleared
Recalled · Class II · 2012Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)
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 23, 2008 as substantially equivalent to K053501 (Bard Access Systems, Inc., 2006) and 1 other predicate after an 82-day review. Its family tree reaches back 7 generations to 2000. 31 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 23, 2008
- Review
- 82 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 7 generations to K001901 (2000). 13 ancestors in all, the oldest K830256 (1983). 31 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 6 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 5 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 4 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 3 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 2 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 1 generation backK053501 PowerpiccBard Access Systems, Inc. · 2006
- This deviceK081904 Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full…Medcomp · 2008
- Descendant · cites it directly · 29 of its ownK091953 Pro-PiccMedcomp · 2009
- Descendant · 2 generations on · 8 of its ownK141151 CT MidlineMedcomp (Medical Components, Inc.) · 2014
- Descendant · 2 generations on · 8 of its ownK093309 Pro-Line CT (Basic Tray) Model MR28036101Medcomp ( Medical Components) · 2009
- Descendant · 3 generations on · 6 of its ownK101329 Synergy CT PiccHealth Line International Corporation · 2010
- Descendant · 3 generations on · 5 of its ownK153393 PowerMidline CatheterC.R. Bard, Inc. · 2016 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K091953Pro-PiccMedcomp · 2009 · cites it directly29descendants
- K141151CT MidlineMedcomp (Medical Components, Inc.) · 2014 · 2 generations on8descendants
- K093309Pro-Line CT (Basic Tray) Model MR28036101Medcomp ( Medical Components) · 2009 · 2 generations on8descendants
- K101329Synergy CT PiccHealth Line International Corporation · 2010 · 3 generations on6descendants
- K153393PowerMidline CatheterC.R. Bard, Inc. · 2016 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −6 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −5 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −4 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −3 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −2 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −1 | K053501 | Powerpicc | Bard Access Systems, Inc. | 2006 | — |
| 0 (this device) | K081904 | Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray) | Medcomp | 2008 | — |
| +1 | K091953 | Pro-Picc | Medcomp | 2009 | — |
| +2 | K141151 | CT Midline | Medcomp (Medical Components, Inc.) | 2014 | — |
| +2 | K093309 | Pro-Line CT (Basic Tray) Model MR28036101 | Medcomp ( Medical Components) | 2009 | — |
| +3 | K101329 | Synergy CT Picc | Health Line International Corporation | 2010 | — |
| +3 | K153393 | PowerMidline Catheter | C.R. Bard, Inc. | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 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.
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 |
|---|---|---|---|
| * | K053501 | PowerpiccSummary page 1…intravascular catheter C.F.R. Section: 880.5970 Class II C. Predicate Device: C.R. Bard, Inc. K053501 6Fr. TL PowerPICCTM Catheter… | 2006 |
| * | K053345 | Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6DSummary page 1…C.R. Bard, Inc. K053501 6Fr. TL PowerPICCTM Catheter Medcomp K053345 Pro-LineTM CT Pressure Injectable CVC. D. Device Description: The P… | 2006 |
What descends from it? (31)
See all 312 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 17, 2012 | Class II | Z-0937-2013 | Component change control | Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle. |
| Dec 13, 2012 | Class II | Z-0898-2013 | Nonconforming Material/Component | The affected product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 7 of the 13 ancestors have a recall of any class.
- Of its descendants, K091953 (Medcomp, 2009) has gone furthest, with 29 descendants of its own.
- 11 other devices also cite its predicate K053501.
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. 2008, 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 TM IT 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. 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/K081904 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081904: Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081904
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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