510(k) · Cleared
Recalled · Class I · 2026Arrow Percutaneous Sheath Introducer Kit AK-07903
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 Nov 30, 1994 after a 327-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 3 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 10 times, including a Class I recall.
- Decided
- Nov 30, 1994
- Review
- 327 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 10 (1 Class I)
- Predicates
- 0
2 later devices descend from it, 1 citing it directly. 2 of the 3 devices in this family, counting this one, have a Class I recall.
- This deviceK940079 Arrow Percutaneous Sheath Introducer Kit AK-07903Arrow Intl., Inc. · 1994
- Descendant · cites it directly · 1 of its ownK011761 Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial…Arrow Intl., Inc. · 2001 · Recalled (Class I)
- Descendant · 2 generations on · 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
- K011761 Mac Two-Lumen Central Venous Kit with Arrowg Ard…cites it directly · 2001
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940079 | Arrow Percutaneous Sheath Introducer Kit AK-07903 | Arrow Intl., Inc. | 1994 | — |
| +1 | K011761 | Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface… | Arrow Intl., Inc. | 2001 | Class I |
| +2 | K032962 | AC 3 Lumen Central Venous Access Kit with Arrowg+Ard Antimicrobial Surface | Arrow Intl., Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 1 |
| 2003 | 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.
2 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011761 | Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral… Class I | 2001 | 1 |
Has anything in its family been recalled? (2 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… |
| Apr 11, 2018 | Class II | Z-2018-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-2017-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1975-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1986-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Dec 22, 2017 | Class II | Z-1334-2018 | Process control | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. |
| Nov 14, 2017 | Class II | Z-1160-2018 | Labeling mix-ups | Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. |
| Nov 24, 2009 | Not classified | Z-0784-2010 | 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. |
| Feb 11, 2009 | Not classified | Z-1492-2009 | 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. |
| Jul 8, 2003 | Not classified | Z-1035-03 | Other | separation of sheath |
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.
- K011761Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral Hemostasis…Arrow Intl., Inc. · 2001 · Cites it directly · ◆ in the 2001 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K011761 (Arrow Intl., Inc., 2001) has gone furthest, with 1 descendant of its own.
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) | — |
https://510kreport.com/device/K940079 · printed Nov 5, 2026
Cite this page
510(k) Report. “K940079: Arrow Percutaneous Sheath Introducer Kit AK-07903.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K940079
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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