510(k) · Cleared
Recalled · Class I · 2026Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral Hemostasis Valve/Side Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · DYB Introducer, Catheter
Cleared on Oct 31, 2001 as substantially equivalent to K993933 (Arrow Intl., Inc., 2000) and 2 other predicates after a 147-day review. Its family tree reaches back 2 generations to 1990. 6 of the 7 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 10 times, including a Class I recall.
- Decided
- Oct 31, 2001
- Review
- 147 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 10 (1 Class I)
- Predicates
- 3
Its longest line of descent runs back 2 generations to K895417 (1990). 5 ancestors in all. 1 later device descends from it, 1 citing it directly. 6 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK895417 Arrow Large-Bore Dual Lumen Hemodialysis KitArrow Intl., Inc. · 1990 · Recalled (Class I)
- 1 generation backK993933 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip…Arrow Intl., Inc. · 2000 · Recalled (Class I)
- This deviceK011761 Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial…Arrow Intl., Inc. · 2001
- Descendant · cites it directly · 0 of its ownK032962 AC 3 Lumen Central Venous Access Kit with Arrowg+Ard Antimicrobial…Arrow Intl., Inc. · 2003
Class I recalls in this family
- K002507 Two-Lumen Central Venous Access Kit with…direct predicate · 2001
- K993933 14 FR Two-Lumen Hemodialysis Catherization Kit…direct predicate · 2000
- K940079 Arrow Percutaneous Sheath Introducer Kit AK-07903direct predicate · 1994
- K900263 Antimicrobial Multi-Lumen Central Venous Catheter2 generations back · 1990
Most influential descendants
Showing 1 of 1 · See all- K032962AC 3 Lumen Central Venous Access Kit with Arrowg+Ard Antimicrobial SurfaceArrow Intl., Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895417 | Arrow Large-Bore Dual Lumen Hemodialysis Kit | Arrow Intl., Inc. | 1990 | Class I |
| −1 | K993933 | 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard… | Arrow Intl., Inc. | 2000 | Class I |
| 0 (this device) | K011761 | Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface… | Arrow Intl., Inc. | 2001 | — |
| +1 | K032962 | AC 3 Lumen Central Venous Access Kit with Arrowg+Ard Antimicrobial Surface | Arrow Intl., Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 1 |
| 1994 | 1 | 1 |
| 2001 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K993933 | 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue…Summary page 1…CFR 870.1340, Introducer Catheter FOZ, Class Il at 21 CFR 880.5200, Intravascular Catheter Legally marketed devices to which the device is substantially equivalent: 1. K993933: Arrow 14 Fr & 12 Fr Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg"ard Blue® Antimicrobial Catheter for Hi… | 2000 |
| * | K002507 | Two-Lumen Central Venous Access Kit with Hemostasis Valve/Side PortSummary page 1…nt: 1. K993933: Arrow 14 Fr & 12 Fr Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg"ard Blue® Antimicrobial Catheter for High Volume Infusions . 2 K002507: Arrow Two-Lumen Central Venous Access Kit with Hemostasis Valve/Side Port 3 K940079: Arrow SUPER ARROWFLEX™ Percutaneous Sheat… | 2001 |
| * | K940079 | Arrow Percutaneous Sheath Introducer Kit AK-07903Summary page 1…ue FlexTip® ARROWg"ard Blue® Antimicrobial Catheter for High Volume Infusions . 2 K002507: Arrow Two-Lumen Central Venous Access Kit with Hemostasis Valve/Side Port 3 K940079: Arrow SUPER ARROWFLEX™ Percutaneous Sheath Introducer Kit with ARROWg"ard Blue® and Arrow Raulerson Syringe Description of devi… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032962 | AC 3 Lumen Central Venous Access Kit with Arrowg+Ard Antimicrobial Surface | 2003 | 0 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2385-2026 | 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… |
| Aug 6, 2019 | Class II | Z-2555-2019 | Packaging process control | Products may contain the incorrect banner card within the kit |
| Apr 11, 2018 | Class II | Z-1983-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Dec 22, 2017 | Class II | Z-1324-2018 | 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-1000-2018 | 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. |
| Nov 27, 2017 | Class II | Z-1002-2018 | 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-2333-2017 | Packaging | Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. |
| Aug 27, 2015 | Class II | Z-2825-2015 | Process control | Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that were packaged with certain products. |
| Aug 6, 2014 | Class II | Z-0066-2015 | Packaging | The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and potentially product sterility. |
| Nov 24, 2009 | Not classified | Z-0783-2010 | Nonconforming Material/Component | Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter. |
The 5 latest of 10 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.
- K002507Two-Lumen Central Venous Access Kit with Hemostasis Valve/Side PortArrow Intl., Inc. · 2001 · Direct predicate · ◆ in the 2001 ancestors bar of FIG. 13 Class I recalls
- K99393314 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume…Arrow Intl., Inc. · 2000 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K940079Arrow Percutaneous Sheath Introducer Kit AK-07903Arrow Intl., Inc. · 1994 · Direct predicate · ◆ in the 1994 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
- K895417Arrow Large-Bore Dual Lumen Hemodialysis KitArrow Intl., Inc. · 1990 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 10.7 years on median.
- 5 of the 5 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K032962 (Arrow Intl., Inc., 2003) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K993933.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
The MAC™Two-Lumen Central Venous Access Device with ARROWg+ard Blue® permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard® technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard® antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
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/K011761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011761: Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral Hemostasis Valve/Side Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011761
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026