510(k) · Cleared
Recalled · Class I · 2026CG+ Arrow Jacc 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.) · OBJ Catheter, Ultrasound, Intravascular
Cleared on Sep 26, 2013 as substantially equivalent to K103255 (Vasonova, Inc., 2011) and 1 other predicate after a 77-day review. Its family tree reaches back 11 generations to 2000. 7 of the 67 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 9 times, including a Class I recall.
- Decided
- Sep 26, 2013
- Review
- 77 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- 9 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 11 generations to K001901 (2000). 63 ancestors in all, the oldest K823434 (1982). 3 later devices descend from it, 2 citing it directly. 7 of the 67 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 backK100635 Arrowgard Evolution Antimicrobial Peripherally Inserted Central…Arrow Intl., Inc. · 2010
- 2 generations backK112896 Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · Recalled (Class I)
- 1 generation backK121501 Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.) · 2012
- This deviceK132133 CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013
- Descendant · cites it directly · 1 of its ownK153423 CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK161765 CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex · 2016
- Descendant · cites it directly · 0 of its ownK150109 Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter…Arrow International (A Subsidiary of Teleflex, Inc.) · 2015
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 backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 7 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 6 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 5 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 4 generations backK080604 Pressure Injfectable PiccArrow International, Inc. · 2008 · Recalled
- 3 generations backK100635 Arrowgard Evolution Antimicrobial Peripherally Inserted Central…Arrow Intl., Inc. · 2010
- 2 generations backK112896 Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · Recalled (Class I)
- 1 generation backK121501 Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.) · 2012
- This deviceK132133 CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · cites it directly1descendant
- K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex · 2016 · 2 generations on0descendants
- K150109Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain…Arrow International (A Subsidiary of Teleflex, Inc.) · 2015 · cites it directly0descendants
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 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −7 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −6 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −5 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −4 | K080604 | Pressure Injfectable Picc | Arrow International, Inc. | 2008 | 1 |
| −3 | K100635 | Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter… | Arrow Intl., Inc. | 2010 | — |
| −2 | K112896 | Arrw Evolution | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | Class I |
| −1 | K121501 | Arrow Jugular Axillo-Subclavian Central Catheter (Jacc) | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | — |
| 0 (this device) | K132133 | CG+ Arrow Jacc Powered by Arrow VPS Stylet | Arrow International (Subsidiary of Teleflex Inc.) | 2013 | — |
| +1 | K153423 | CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016 | Class I |
| +2 | K161765 | CG+ Arrow JACC | Arrow International, Inc. (Subsidiary of Teleflex | 2016 | — |
| +1 | K150109 | Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC)… | Arrow International (A Subsidiary of Teleflex, Inc.) | 2015 | — |
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 |
| 1989 | 1 | 0 |
| 1990 | 1 | 1 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 1 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 1 | 1 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 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.
7 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 OBJ device
- #1 K242893 VERAFEYE System VERAFEYE Imaging Catheter &…score 23.8 · 30 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 |
|---|---|---|---|
| * | K103255 | Vascular Positioning System TM (VPS TM System) StyletSummary page 1…cular catheter per 21 CFR: 880.5970 Classification Name, Stylet: Diagnostic Intravascular Catheter per 21 CFR 870.1200 Predicate Devices * K 103255: Vascular Positioning System (VPS System) Stylet * K121 501: Arrowo Pressure Injectable Jugular Axillo-subclavian Central… | 2011 |
| * | K121501 | Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Summary page 1…ation Name, Stylet: Diagnostic Intravascular Catheter per 21 CFR 870.1200 Predicate Devices * K 103255: Vascular Positioning System (VPS System) Stylet * K121 501: Arrowo Pressure Injectable Jugular Axillo-subclavian Central CatheterTM (JACCTM) with Chlorag~ardo Antimicrobial and An… | 2012 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2379-2026 | 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-1816-2019 | Process control | Lidstock states the incorrect expiration date for the product |
| Apr 23, 2019 | Class II | Z-1817-2019 | Process control | Lidstock states the incorrect expiration date for the product |
| Apr 23, 2019 | Class II | Z-1815-2019 | Process control | Lidstock states the incorrect expiration date for the product |
| Apr 23, 2019 | Class II | Z-1806-2019 | Process control | Lidstock states the incorrect expiration date for the product |
| Apr 23, 2019 | Class II | Z-1814-2019 | Process control | Lidstock states the incorrect expiration date for the product |
| Apr 23, 2019 | Class II | Z-1812-2019 | Process control | Lidstock states the incorrect expiration date for the product |
| Apr 11, 2018 | Class II | Z-2015-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| 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… |
The 5 latest of 9 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.
- K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · 2 generations back · ◆ in the 2007 ancestors bar of FIG. 15 Class I recalls
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · 3 generations back · ◆ in the 1990 ancestors bar of FIG. 12 Class I recalls
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 3 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
- K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 24 of the 63 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K153423 (Arrow International, Inc. (Subsidiary of Teleflex, Inc.), 2016) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K103255.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OBJ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBJ
35in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBJ
2in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OBJ
791in 2025
MAUDE reports naming product code OBJ, 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 | 3 | 74 | 0 | 0 |
| 2008 | 6 | 100 | 0 | 6 |
| 2009 | 3 | 108 | 0 | 22 |
| 2010 | 1 | — | 0 | 39 |
| 2011 | 4 | 109 | 0 | 47 |
| 2012 | 3 | 136 | 0 | 53 |
| 2013 | 4 | 96 | 0 | 328 |
| 2014 | 3 | 30 | 0 | 609 |
| 2015 | 4 | 131 | 2 | 401 |
| 2016 | 4 | 94 | 0 | 515 |
| 2017 | 6 | 45 | 2 | 524 |
| 2018 | 2 | — | 2 | 542 |
| 2019 | 1 | — | 0 | 237 |
| 2020 | 4 | 135 | 2 | 288 |
| 2021 | 3 | 29 | 0 | 353 |
| 2022 | 3 | 63 | 0 | 473 |
| 2023 | 3 | 63 | 0 | 697 |
| 2024 | 3 | 131 | 0 | 1,154 |
| 2025 | 7 | 35 | 0 | 791 |
| 2026 | 4 | 81 | 1 (1) | — |
What is it indicated for?
The Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter™ with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable JACC™ may…
Read the full statement (377 words)
The Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter™ with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable JACC™ may not exceed 300 psi. The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness was evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.
The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K132133 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132133: CG+ Arrow Jacc Powered by Arrow VPS Stylet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132133
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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