510(k) · Cleared
Recalled · Class II · 2023Arrow Picc Powered by Arrow VPS Stylet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International (Subsidiary of Teleflex Inc.) · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Sep 7, 2012 as substantially equivalent to K103255 (Vasonova, Inc., 2011) and 2 other predicates after a 67-day review. Its family tree reaches back 10 generations to 2000. 3 of the 56 devices in its family, counting itself, have a Class I recall. It has been recalled 10 times.
- Decided
- Sep 7, 2012
- Review
- 67 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 10
- Predicates
- 3
Its longest line of descent runs back 10 generations to K001901 (2000). 55 ancestors in all, the oldest K823434 (1982). No later device cites it as a predicate yet. 3 of the 56 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 6 generations between
- 3 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- 2 generations backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- 1 generation backK103255 Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 2011 · Recalled
- This deviceK121941 Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012
Show all 10 generations
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 8 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 7 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 6 generations backK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
- 5 generations backK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
- 4 generations backK081625 Flowpicc StyletVasonova, Inc. · 2008
- 3 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- 2 generations backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- 1 generation backK103255 Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 2011 · Recalled
- This deviceK121941 Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −9 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −8 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −7 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −6 | K060341 | Sherlock Tip Location System (TLS) | C.R. Bard, Inc. | 2006 | — |
| −5 | K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | C.R. Bard, Inc. | 2006 | 18 |
| −4 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| −3 | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | 11 |
| −2 | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | — |
| −1 | K103255 | Vascular Positioning System TM (VPS TM System) Stylet | Vasonova, Inc. | 2011 | 4 |
| 0 (this device) | K121941 | Arrow Picc Powered by Arrow VPS Stylet | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 2 | 1 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 1 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2008 | 3 | 0 |
| 2012 | 1 | 1 |
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.
3 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 |
|---|---|---|---|
| * | K103255 | Vascular Positioning System TM (VPS TM System) StyletSummary page 3…aracteristics and Substantial Equivalence The Arrow P1CC powered by Arrow VPS Stylet is substantially equivalent to the Vascular Positioning System (VPS System) Stylet (K 103255), ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (P1CC) (KI 113277) and the Pressure Injectable P1CC… | 2011 |
| * | K113277 | Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsSummary page 1…ification Name, Stylet: Diagnostic Intravascular Catheter per 21 CER 870.1200 Predicate Devices * K(103255: Vascular Positioning System (VPS System) Stylet * K(113277: ArrowAD VANTAGES Pressure Injectable Peripherally Inserted Central Catheter (P1CC) * K(080604: Pressure Injectable P1C… | 2012 |
| * | K080604 | Pressure Injfectable PiccSummary page 3…g System (VPS System) Stylet (K 103255), ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (P1CC) (KI 113277) and the Pressure Injectable P1CC (K080604) in terms of indications for use, design, manufacturing process, functional performanice, and materials of construction. The subj… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2023 | Class II | Z-2591-2023 | Under Investigation by firm | This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. |
| Oct 17, 2017 | Class II | Z-0690-2018 | Mixed-up of materials/components | The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter. |
| Jul 25, 2017 | Class II | Z-0601-2018 | Packaging process control | Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter.… |
| Jun 1, 2017 | Class II | Z-0180-2018 | Mixed-up of materials/components | There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths. |
| Jun 1, 2017 | Class II | Z-0181-2018 | Mixed-up of materials/components | There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths. |
| Oct 16, 2015 | Class II | Z-0207-2016 | Unknown/Undetermined by firm | Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may… |
| Jul 30, 2015 | Class II | Z-2462-2015 | Unknown/Undetermined by firm | the catheter peel-away component hub tabs may prematurely detach. One injury reported. |
| Jul 30, 2015 | Class II | Z-2489-2015 | Under Investigation by firm | saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported. |
| Jan 9, 2015 | Class III | Z-1030-2015 | Packaging process control | Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated. |
| Mar 24, 2014 | Class II | Z-1494-2014 | Labeling mix-ups | Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter. |
The 5 latest of 10 recalls; the web page lists all.
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.
- K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc. · 2012 · Direct predicate · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
- 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 12 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 20 of the 55 ancestors have a recall of any class; 3 have a Class I recall.
- 4 other devices also cite its predicate K103255.
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. 2012, 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 Pressure Injectable P1CC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of power injectors used with the pressure injectable P1CC catheter may not exceed 300 psi. The maximum pressure injection flow rate ranges from 4 mI/sec; to 6 mt/sec. Refer to the product…
Read the full statement (308 words)
The Pressure Injectable P1CC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of power injectors used with the pressure injectable P1CC catheter may not exceed 300 psi. The maximum pressure injection flow rate ranges from 4 mI/sec; to 6 mt/sec. Refer to the product specific labeling for the maximum pressure injection flow rate for the specific lumen being used for pressure injection.
The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffnuess for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location.
The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained. NOTE: If a steady Blue Bullseye is not obtained, standard hospital practice should be followed to confirm catheter tip location.
Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121941 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121941: Arrow Picc Powered by Arrow VPS Stylet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121941
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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