510(k) · Cleared
Recalled · 2004Merit Mak (Mini Access Kit)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Sep 3, 2003 after a 93-day review. The FDA summary names its predicate without a number. 7 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 3, 2003
- Review
- 93 days
- Class
- Class II
- Product code
- DRE
- Recalls
- 3
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK031691 Merit Mak (Mini Access Kit)Merit Medical Systems, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK091584 Merit Mak (Mini Access Kit) with Palladium Tip Guide WireMerit Medical Systems, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK232609 Micro Ace™ Advanced Micro Access SystemMerit Medical Systems, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK130730 V-Stick Vascular Access SetArgon Medical · 2013
- Descendant · cites it directly · 0 of its ownK261640 Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland, Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK253741 V•Stick™ Vascular Access SetArgon Medical Devices, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K091584Merit Mak (Mini Access Kit) with Palladium Tip Guide WireMerit Medical Systems, Inc. · 2009 · cites it directly2descendants
- K232609Micro Ace™ Advanced Micro Access SystemMerit Medical Systems, Inc. · 2023 · cites it directly1descendant
- K130730V-Stick Vascular Access SetArgon Medical · 2013 · 2 generations on1descendant
- K261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland, Ltd. · 2026 · cites it directly0descendants
- K253741V•Stick™ Vascular Access SetArgon Medical Devices, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031691 | Merit Mak (Mini Access Kit) | Merit Medical Systems, Inc. | 2003 | — |
| +1 | K091584 | Merit Mak (Mini Access Kit) with Palladium Tip Guide Wire | Merit Medical Systems, Inc. | 2009 | — |
| +1 | K232609 | Micro Ace™ Advanced Micro Access System | Merit Medical Systems, Inc. | 2023 | — |
| +2 | K130730 | V-Stick Vascular Access Set | Argon Medical | 2013 | — |
| +1 | K261640 | Merit MAK Nitinol/Gold-Tungsten Guide Wire | Merit Medical Ireland, Ltd. | 2026 | — |
| +3 | K253741 | V•Stick™ Vascular Access Set | Argon Medical Devices, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 DRE? 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 DRE device
- #1 K261310 FlexTract Deflectable-Rotational Dilator…score 12.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Micropuncture Introducer Set Named without a submission number |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 20, 2004 | Not classified | Z-1311-04 | Other | Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt. |
| Jul 20, 2004 | Not classified | Z-1310-04 | Other | Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt. |
| Jul 20, 2004 | Not classified | Z-1309-04 | Other | Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091584 (Merit Medical Systems, Inc., 2009) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DRE devicesDRE Dilator, Vessel, For Percutaneous Catheterization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRE
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRE
1in 2016
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DRE
356in 2025
MAUDE reports naming product code DRE, 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 | 5 | 160 | 0 | 81 |
| 2008 | 2 | — | 0 | 38 |
| 2009 | 2 | — | 2 | 69 |
| 2010 | 1 | — | 2 | 73 |
| 2011 | 1 | — | 1 | 90 |
| 2012 | 1 | — | 0 | 132 |
| 2013 | 4 | 111 | 0 | 120 |
| 2014 | 6 | 72 | 0 | 82 |
| 2015 | 4 | 30 | 1 | 82 |
| 2016 | 3 | 90 | 1 | 84 |
| 2017 | 4 | 108 | 0 | 101 |
| 2018 | 2 | — | 0 | 126 |
| 2019 | 3 | 68 | 0 | 144 |
| 2020 | 3 | 30 | 0 | 120 |
| 2021 | 1 | — | 0 | 115 |
| 2022 | 3 | 261 | 0 | 136 |
| 2023 | 2 | — | 0 | 386 |
| 2024 | 1 | — | 0 | 325 |
| 2025 | 3 | 31 | 0 | 356 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The Merit® MAK (Mini Access Kit) is intended for percutaneous placement of a 0.035” (0.89mm) or 0.038” (0.97mm) guide wire into the vascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031691 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031691: Merit Mak (Mini Access Kit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031691
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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