510(k) · Cleared
Recalled · 2009Arrowgard Blue Quad-Lumen Central Venous Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Aug 21, 1997 after a 416-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 of the 60 devices in its family, counting itself, have a Class I recall. 59 later devices descend from it. It has been recalled once.
- Decided
- Aug 21, 1997
- Review
- 416 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 1
- Predicates
- 0
59 later devices descend from it, 4 citing it directly. 4 of the 60 devices in this family, counting this one, have a Class I recall.
- This deviceK962577 Arrowgard Blue Quad-Lumen Central Venous CatheterArrow Intl., Inc. · 1997
- Descendant · cites it directly · 32 of its ownK060174 Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc. · 2006
- Descendant · 2 generations on · 31 of its ownK081113 Cook and Cook Spectrum Central Venous CathetersCook, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 26 of its ownK101326 NMI ICNavilyst Medical, Inc. · 2010
- Descendant · 4 generations on · 23 of its ownK121089 Nmi Picc IiiNavilyst Medical, Inc. · 2012
- Descendant · 4 generations on · 14 of its ownK111906 Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 59 · See all- K060174Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc. · 2006 · cites it directly32descendants
- K081113Cook and Cook Spectrum Central Venous CathetersCook, Inc. · 2008 · 2 generations on31descendants
- K101326NMI ICNavilyst Medical, Inc. · 2010 · 3 generations on26descendants
- K121089Nmi Picc IiiNavilyst Medical, Inc. · 2012 · 4 generations on23descendants
- K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962577 | Arrowgard Blue Quad-Lumen Central Venous Catheter | Arrow Intl., Inc. | 1997 | — |
| +1 | K060174 | Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-Abrm | Cook, Inc. | 2006 | — |
| +2 | K081113 | Cook and Cook Spectrum Central Venous Catheters | Cook, Inc. | 2008 | 105 |
| +3 | K101326 | NMI IC | Navilyst Medical, Inc. | 2010 | — |
| +4 | K121089 | Nmi Picc Iii | Navilyst Medical, Inc. | 2012 | — |
| +4 | K111906 | Xcela Hybrid Picc with Pasv Valve Technology | Navilyst Medical, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 1 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 1 |
| 2014 | 4 | 1 |
| 2015 | 6 | 0 |
| 2016 | 7 | 1 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (59)
See all 594 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060174 | Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-Abrm | 2006 | 32 |
| K071538 | Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheter Class I | 2007 | 14 |
| K014241 | Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500D | 2003 | 11 |
| K160747 | Angel Catheter | 2016 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 11, 2009 | Not classified | Z-1497-2009 | Device Design | Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism. |
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.
- K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 15 Class I recalls
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 3 generations on · ◆ in the 2013 descendants 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 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K060174 (Cook, Inc., 2006) has gone furthest, with 32 descendants of its own.
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.
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 multiple-flumen catheter permits venous access to the central circulation.
The Arrow antiseptic surface catheter is intended to help provide protection against catheter related infections. The catheter is not intended to be used as a treatment for existing infections nor is it indicated for longterm use.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962577 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962577: Arrowgard Blue Quad-Lumen Central Venous Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962577
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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