510(k) · Cleared
ClearedR4 Vascular Inc. Pegasus CT Picc, Model 500005-001,002, 004, 005, 500004-001, 002,004,005
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R4 Vascular, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Aug 20, 2007 as substantially equivalent to K053345 (Medcomp, 2006) after a 97-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Aug 20, 2007
- Review
- 97 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001901 (2000). 9 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet.
- 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 backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 3 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 2 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 1 generation backK053345 Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6DMedcomp · 2006 · Recalled
- This deviceK071361 R4 Vascular Inc. Pegasus CT Picc, Model 500005-001,002, 004, 005…R4 Vascular, Inc. · 2007
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 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −3 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −2 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −1 | K053345 | Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D | Medcomp | 2006 | 1 |
| 0 (this device) | K071361 | R4 Vascular Inc. Pegasus CT Picc, Model 500005-001,002, 004, 005, 500004-001… | R4 Vascular, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2004 | 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? (1)
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…ame: Medcomp Pro-Line CT Power Injectable CVC Catheter Common/Usual Name: CVC Catheter Classification Name: Long Term Intravascular Catheter (US) Premarket Notification: K053345, concurrence date-December 20, 2005 I-I Device Description o T… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 6 of the 9 ancestors have a recall of any class.
- 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. 2007, 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 R4 VASCULAR INC. PEGASUS CT PICC IS INDICATED FOR SHORT TERM AND 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 PRESSURE OF INJECTORS USED WITH THE 5F AND 6F PEGASUS CT PICC CATHETER MAY NOT EXCEED 300PSI. MAXIMUM RECOMMENDED INFUSION RATE IS 5CC/SEC FOR 5F AND 6F CATHETER. THE MAXIMUM PRESSURE OF INJECTORS USED WITH THE 4F PEGASUS CT PICC CATHETER MAY NOT EXCEED 200PSI. MAXIMUM RECOMMENDED INFUSION RATE IS 4CC/SEC FOR A 4F CATHETER.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071361: R4 Vascular Inc. Pegasus CT Picc, Model 500005-001,002, 004, 005, 500004-001, 002,004,005.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071361
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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