510(k) · Cleared
Recalled · Class I · 2026CG+ Arrow 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, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Apr 26, 2013 as substantially equivalent to K123759 (Arrow International, Inc. (Subsidiary of Teleflex, 2013) after a 28-day review. Its family tree reaches back 11 generations to 2000. 5 of the 61 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 4 times, including a Class I recall.
- Decided
- Apr 26, 2013
- Review
- 28 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 4 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 11 generations to K001901 (2000). 58 ancestors in all, the oldest K823434 (1982). 2 later devices descend from it, 1 citing it directly. 5 of the 61 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations between
- 3 generations backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- 2 generations backK103255 Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 2011 · Recalled
- 1 generation backK123759 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex · 2013
- This deviceK130876 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK141618 Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet…Arrow International, Inc (Subsidiary of Teleflex I · 2014
- Descendant · 2 generations on · 0 of its ownK153487 CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet…Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · Recalled (Class I)
Show all 11 generations
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 10 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 9 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 8 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 7 generations backK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
- 6 generations backK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
- 5 generations backK081625 Flowpicc StyletVasonova, Inc. · 2008
- 4 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- 3 generations backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- 2 generations backK103255 Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 2011 · Recalled
- 1 generation backK123759 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex · 2013
- This deviceK130876 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See all- K141618Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet PlusArrow International, Inc (Subsidiary of Teleflex I · 2014 · cites it directly1descendant
- K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −10 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −9 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −8 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −7 | K060341 | Sherlock Tip Location System (TLS) | C.R. Bard, Inc. | 2006 | — |
| −6 | K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | C.R. Bard, Inc. | 2006 | 18 |
| −5 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| −4 | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | 11 |
| −3 | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | — |
| −2 | K103255 | Vascular Positioning System TM (VPS TM System) Stylet | Vasonova, Inc. | 2011 | 4 |
| −1 | K123759 | CG+ Arrow Picc Powered by Arrow VPS Stylet | Arrow International, Inc. (Subsidiary of Teleflex | 2013 | — |
| 0 (this device) | K130876 | CG+ Arrow Picc Powered by Arrow VPS Stylet | Arrow International, Inc. | 2013 | — |
| +1 | K141618 | Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet Plus | Arrow International, Inc (Subsidiary of Teleflex I | 2014 | — |
| +2 | K153487 | CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016 | Class I |
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 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 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.
5 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? (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 |
|---|---|---|---|
| * | K123759 | CG+ Arrow Picc Powered by Arrow VPS StyletSummary page 1…ter (P1CC) Classification Name, Catheter: Percutaneous, implanted, long-term intravascular catheter per 21 CFR: 880.5970 Predicate Devices *K 123759: CG+ Arrow P1CC powered by Arrow VPS Stylet Device Description The CG± Arrow PICC powered by Arrow VPS Stylet has the following… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141618 | Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet Plus | 2014 | 1 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2378-2026 | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a… |
| Apr 23, 2019 | Class II | Z-1809-2019 | Process control | Lidstock states the incorrect expiration date for the product |
| Apr 11, 2018 | Class II | Z-2025-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| 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. |
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.
- K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 2 generations back · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 7 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 · 8 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
- K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 20 of the 58 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K141618 (Arrow International, Inc (Subsidiary of Teleflex I, 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K123759.
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. 2013, 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 with Chloag4-ard Antimicrobial and Antithrombogenic Technology is indicated for shoam-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling. infusion, pressure injection OfContras media and allows for central venous pressure, monitoring;The maximum Pressure of pressuire injection equipment used with the pressure injectable PICC cathecter mnay not exced 30Oiti.- Chionrard…
Read the full statement (351 words)
The Pressure Injectable P1CC with Chloag4-ard Antimicrobial and Antithrombogenic Technology is indicated for shoam-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling. infusion, pressure injection OfContras media and allows for central venous pressure, monitoring;The maximum Pressure of pressuire injection equipment used with the pressure injectable PICC cathecter mnay not exced 30Oiti.-
Chionrard Technology trmentC On the extl surface! Of the catheter body as well as the entire fluid pathway of thtecatheter has been shtown to be effecive in reducing microbial colonization and thrombus accumulation on catheter sturfaces. Antimicrobial and antithroibogiciic effectiveness were evaluated using in tiroand in v/io test methods and no correlation between these lest methods and clinical outcome has currently been ascented. It is not intended to be used for the treatment of existing; infections or vein thrombosis.
The VI'S Stylet and Console arc indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the cathetear, intravascular capability for ECG detection and recording and intraviactlar ultrasound for catheter guiding and positioning. The VPS Stylet, whten used wvith the VI'S Console, provides real-timei 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 inthe desired location.
The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venious cathete tip placement confirmtation in adult patients when a steady" Blue Bullseye isobtained. NOTE: If a steady Blue Bullseye is not obtained. standard hospital practice should be followed to conifirm catheter tip location.
Limiting hut not cointraindicated situations for this technique are in patients where alterations of cardiac rttythm change the presentation of the P-wave asin atrial fibrillation. atrial fautter. severe tachycardia and pacennaker-driven rhythm. and in central venous catheteration procedures performed through femnoral 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 toconifirm catheter tip location.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130876 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130876: CG+ Arrow Picc Powered by Arrow VPS Stylet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130876
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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