510(k) · Cleared
ClearedV-Stick Vascular Access Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argon Medical · DYB Introducer, Catheter
Cleared on Nov 22, 2013 as substantially equivalent to K011790 (Medical Device Technologies, Inc., 2001) and 2 other predicates after a 249-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.
- Decided
- Nov 22, 2013
- Review
- 249 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K031691 (2003). 4 ancestors in all, the oldest K851834 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK031691 Merit Mak (Mini Access Kit)Merit Medical Systems, Inc. · 2003 · Recalled
- 1 generation backK091584 Merit Mak (Mini Access Kit) with Palladium Tip Guide WireMerit Medical Systems, Inc. · 2009
- This deviceK130730 V-Stick Vascular Access SetArgon Medical · 2013
- Descendant · cites it directly · 0 of its ownK253741 V•Stick™ Vascular Access SetArgon Medical Devices, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253741V•Stick™ Vascular Access SetArgon Medical Devices, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031691 | Merit Mak (Mini Access Kit) | Merit Medical Systems, Inc. | 2003 | 3 |
| −1 | K091584 | Merit Mak (Mini Access Kit) with Palladium Tip Guide Wire | Merit Medical Systems, Inc. | 2009 | — |
| 0 (this device) | K130730 | V-Stick Vascular Access Set | Argon Medical | 2013 | — |
| +1 | K253741 | V•Stick™ Vascular Access Set | Argon Medical Devices, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
Planning a device in DYB? 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 |
|---|---|---|---|
| * | K011790 | Microcruiser Plus Introducer SetSummary page 2…Stick Vascular Access Set is similar in design components, dimensions, and materials to the predicate devices. The MicroCruiser® [KO011790], Merit MAK [K(09 1584], and W-Stick are all available in the same French and 0.018" guidewire sizes.… | 2001 |
| * | K091584 | Merit Mak (Mini Access Kit) with Palladium Tip Guide WireSummary page 1…21 CFR 870.1340 Class 11 Legally marketed KOI 11790 MicroCruiser® Plus Introducer Set device to which the K091 584 Merit MAK (Mini Access Kit) device is substantially equivalent: K85 1834 Manan GWI Guidewire In… | 2009 |
| * | K851834 | Manan Gwi Guide Wire IntroducerSummary page 1…790 MicroCruiser® Plus Introducer Set device to which the K091 584 Merit MAK (Mini Access Kit) device is substantially equivalent: K85 1834 Manan GWI Guidewire Introducer Description of the The V.StickTM Vascular Access Set assists in gaining vascular… | 1985 |
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 |
|---|---|---|---|
| K253741 | V•Stick™ Vascular Access Set | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K253741 (Argon Medical Devices, Inc., 2025) has gone furthest, with 0 descendants 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. 2013, this device’s year, is highlighted.
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?
V.StickTm Vascular Access Sets intended for use in the introduction and placement of guidewires and/or catheters
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130730 · printed Nov 3, 2026
Cite this page
510(k) Report. “K130730: V-Stick Vascular Access Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K130730
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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