510(k) · Cleared
ClearedArrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International (A Subsidiary of Teleflex, Inc.) · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Jun 5, 2015 as substantially equivalent to K132133 (Arrow International (Subsidiary of Teleflex Inc.), 2013) and 3 other predicates after a 136-day review. Its family tree reaches back 14 generations to 2000. 6 of the 87 devices in its family, counting itself, have a Class I recall.
- Decided
- Jun 5, 2015
- Review
- 136 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K001901 (2000). 86 ancestors in all, the oldest K823434 (1982). No later device cites it as a predicate yet. 6 of the 87 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 10 generations between
- 3 generations backK131942 Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc. · 2013
- 2 generations backK133264 Nmi Picc IiiNavilyst Medical, Inc. · 2013
- 1 generation backK140266 Nmi Picc IVNavilyst Medical, Inc. · 2014
- This deviceK150109 Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter…Arrow International (A Subsidiary of Teleflex, Inc.) · 2015
Show all 14 generations
- Root · 14 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 13 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 12 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 11 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 10 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 9 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 8 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 7 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- 6 generations backK101326 NMI ICNavilyst Medical, Inc. · 2010
- 5 generations backK111906 Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011
- 4 generations backK122882 Nmi Hpicc IiiNavilyst Medical, Inc. · 2012
- 3 generations backK131942 Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc. · 2013
- 2 generations backK133264 Nmi Picc IiiNavilyst Medical, Inc. · 2013
- 1 generation backK140266 Nmi Picc IVNavilyst Medical, Inc. · 2014
- This deviceK150109 Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter…Arrow International (A Subsidiary of Teleflex, Inc.) · 2015
Class I recalls in this family
- K132133 CG+ Arrow Jacc Powered by Arrow VPS Styletdirect predicate · 2013
- K071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus…direct predicate · 2007
- K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…2 generations back · 2000
- K900263 Antimicrobial Multi-Lumen Central Venous Catheter2 generations back · 1990
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −13 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −12 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −11 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −10 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −9 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −8 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −7 | K061179 | Powerhickman Long-Term Intravascular Catheter | C.R. Bard, Inc. | 2006 | — |
| −6 | K101326 | NMI IC | Navilyst Medical, Inc. | 2010 | — |
| −5 | K111906 | Xcela Hybrid Picc with Pasv Valve Technology | Navilyst Medical, Inc. | 2011 | — |
| −4 | K122882 | Nmi Hpicc Iii | Navilyst Medical, Inc. | 2012 | — |
| −3 | K131942 | Nmi Picc Iii Catheter, Nmi Hpicc Iii Catheter | Navilyst Medical, Inc. | 2013 | — |
| −2 | K133264 | Nmi Picc Iii | Navilyst Medical, Inc. | 2013 | — |
| −1 | K140266 | Nmi Picc IV | Navilyst Medical, Inc. | 2014 | — |
| 0 (this device) | 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 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 1 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 1 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 1 |
| 2013 | 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.
6 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K132133 | CG+ Arrow Jacc Powered by Arrow VPS StyletSummary page 4…Name Pressure Injectable JACC with Chlorag+ard Antimicrobial and Antithrombogenic Technology. K132133 Arrow International Arrow, Arrowg+ard and Arrowg+ard Blue Plus… | 2013 |
| * | K071538 | Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterSummary page 4…K132133 Arrow International Arrow, Arrowg+ard and Arrowg+ard Blue Plus K071538 Arrow International Pressure-Injectable Central Venous Catheters NMI PICC IV (BioFlo PICC with Endexo Tech… | 2007 |
| * | K140266 | Nmi Picc IVSummary page 4…K071538 Arrow International Pressure-Injectable Central Venous Catheters NMI PICC IV (BioFlo PICC with Endexo Technology) K140266 Navilyst Medical 6 Fr, 3-Lumen Pressure Injectable PICC K080604 Arrow Intern… | 2014 |
| * | K080604 | Pressure Injfectable PiccSummary page 4…o PICC with Endexo Technology) K140266 Navilyst Medical 6 Fr, 3-Lumen Pressure Injectable PICC K080604 Arrow International Reference Device Name 510(k) Original A… | 2008 |
| † | K113225 | Nylus Picc | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
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.
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · Direct predicate · ◆ in the 2013 ancestors bar of FIG. 11 Class I recall
- K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · Direct predicate · ◆ in the 2007 ancestors bar of FIG. 15 Class I recalls
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · 2 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 · 2 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
- K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 3 generations back · ◆ in the 2012 ancestors 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 15 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 29 of the 86 ancestors have a recall of any class; 6 have a Class I recall.
- 1 other device also cites its predicate K132133.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology is indicated for short-term (up to 30-days) access to the central venous system for intravenous therapy, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of power injector equipment used with the Arrow Pressure Injectable JACC with Sustain Technology 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150109 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150109: Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150109
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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