510(k) · Decided
Recalled · Class I · 2026Antimicrobial Multi-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 Jul 24, 1990 after a 187-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 of the 34 devices in its family, counting itself, have a Class I recall. 33 later devices descend from it. It has been recalled 12 times, including 2 Class I recalls.
- Decided
- Jul 24, 1990
- Review
- 187 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 12 (2 Class I)
- Predicates
- 0
33 later devices descend from it, 8 citing it directly. 7 of the 34 devices in this family, counting this one, have a Class I recall.
- This deviceK900263 Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990
- Descendant · cites it directly · 14 of its ownK071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable…Arrow International, Inc. · 2007 · Recalled (Class I)
- Descendant · cites it directly · 8 of its ownK993933 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip…Arrow Intl., Inc. · 2000 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK121501 Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.) · 2012
- Descendant · 2 generations on · 3 of its ownK190855 BD Acute Central LineBard Access Systems, Inc. (Bard Has Joined Bd) · 2019
- Descendant · 3 generations on · 3 of its ownK132133 CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · Recalled (Class I)
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus…cites it directly · 2007
- K993933 14 FR Two-Lumen Hemodialysis Catherization Kit…cites it directly · 2000
- K143102 Multi-Lumen Acute Hemodialysis Catheter for High…2 generations on · 2015
- K011761 Mac Two-Lumen Central Venous Kit with Arrowg Ard…2 generations on · 2001
Most influential descendants
Showing 5 of 33 · See all- K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · cites it directly14descendants
- K99393314 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue…Arrow Intl., Inc. · 2000 · cites it directly8descendants
- K121501Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.) · 2012 · 2 generations on4descendants
- K190855BD Acute Central LineBard Access Systems, Inc. (Bard Has Joined Bd) · 2019 · 2 generations on3descendants
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900263 | Antimicrobial Multi-Lumen Central Venous Catheter | Arrow Intl., Inc. | 1990 | — |
| +1 | K071538 | Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous… | Arrow International, Inc. | 2007 | Class I |
| +1 | K993933 | 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard… | Arrow Intl., Inc. | 2000 | Class I |
| +2 | K121501 | Arrow Jugular Axillo-Subclavian Central Catheter (Jacc) | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | — |
| +2 | K190855 | BD Acute Central Line | Bard Access Systems, Inc. (Bard Has Joined Bd) | 2019 | — |
| +3 | K132133 | CG+ Arrow Jacc Powered by Arrow VPS Stylet | Arrow International (Subsidiary of Teleflex Inc.) | 2013 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 1 |
| 2001 | 1 | 1 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 1 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 1 |
| 2015 | 2 | 1 |
| 2016 | 4 | 1 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (33)
See all 338 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071538 | Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheter Class I | 2007 | 14 |
| K993933 | 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue… Class I | 2000 | 8 |
| K961392 | Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II | 1997 | 3 |
| K021130 | Specath Central Venous Catheter Kits | 2003 | 2 |
| K012193 | Amc Antimicrobial Pin/Wire Sleeve | 2002 | 2 |
| K073520 | Angiotech CVC | 2008 | 0 |
| K063245 | Elutia Coated Closed Surgical Wound Drain | 2007 | 0 |
| K961194 | Antimicrobial Mediastinal Silicone Drain | 1996 | 0 |
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-2376-2026 | 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… |
| May 17, 2019 | Class II | Z-0053-2020 | Employee error | Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner. |
| Jul 3, 2018 | Class II | Z-2886-2018 | Employee error | One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it contains a 2-lumen, 5 Fr x 8 cm catheter. No patient… |
| Apr 11, 2018 | Class II | Z-1985-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1984-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Dec 22, 2017 | Class II | Z-1333-2018 | Process control | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. |
| Nov 27, 2017 | Class II | Z-1001-2018 | Error in labeling | Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information. |
| May 9, 2017 | Class II | Z-2337-2017 | Packaging | The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infusions of fluids, medications, or… |
| May 3, 2012 | Class I | Z-1830-2012 | Labeling mix-ups | Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status. |
| Jul 29, 2010 | Not classified | Z-2496-2010 | Mixed-up of materials/components | Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle |
| Feb 11, 2009 | Not classified | Z-1499-2009 | 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. |
| Sep 16, 2003 | Not classified | Z-0082-04 | Other | wrong product in box |
The 5 latest of 12 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.
- 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
- K99393314 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume…Arrow Intl., Inc. · 2000 · Cites it directly · ◆ in the 2000 descendants bar of FIG. 11 Class I recall
- K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K011761Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral Hemostasis…Arrow Intl., Inc. · 2001 · 2 generations on · ◆ in the 2001 descendants bar of FIG. 11 Class I recall
- 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
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K071538 (Arrow International, Inc., 2007) has gone furthest, with 14 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 | — |
https://510kreport.com/device/K900263 · printed Nov 3, 2026
Cite this page
510(k) Report. “K900263: Antimicrobial Multi-Lumen Central Venous Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K900263
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026