510(k) · Cleared

Cleared

Merit Mak (Mini Access Kit) with Palladium Tip Guide Wire

K091584510(k) TraditionalCleared Oct 9, 2009129-day reviewClass II21 CFR 870.1310

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Merit Medical Systems, Inc. · DRE Dilator, Vessel, For Percutaneous Catheterization

Cleared on Oct 9, 2009 as substantially equivalent to K031691 (Merit Medical Systems, Inc., 2003) after a 129-day review. Its family tree reaches back 1 generation to 2003. 2 later devices descend from it.

Decided: Oct 9, 2009
Review: 129 days
Class: Class II
Product code: DRE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K031691 (2003). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK031691 Merit Mak (Mini Access Kit)Merit Medical Systems, Inc. · 2003 · Recalled
This deviceK091584 Merit Mak (Mini Access Kit) with Palladium Tip Guide WireMerit Medical Systems, Inc. · 2009
Descendant · cites it directly · 1 of its ownK130730 V-Stick Vascular Access SetArgon Medical · 2013
Descendant · 2 generations on · 0 of its ownK253741 V•Stick™ Vascular Access SetArgon Medical Devices, Inc. · 2025

Most influential descendants

Showing 2 of 2 · See all

K130730V-Stick Vascular Access SetArgon Medical · 2013 · cites it directly1descendant
K253741V•Stick™ Vascular Access SetArgon Medical Devices, Inc. · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K031691	Merit Mak (Mini Access Kit)	Merit Medical Systems, Inc.	2003	3
0 (this device)	K091584	Merit Mak (Mini Access Kit) with Palladium Tip Guide Wire	Merit Medical Systems, Inc.	2009	—
+1	K130730	V-Stick Vascular Access Set	Argon Medical	2013	—
+2	K253741	V•Stick™ Vascular Access Set	Argon Medical Devices, Inc.	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2025	1	0

FIG. 1 — Lineage of K091584, 2003–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K031691	Merit Mak (Mini Access Kit) Summary page 1 …Classification Name: Vessel Dilator for Percutaneous Catheterization Premarket Notification: K031691 Manufacturer: Merit Medical Systems, Inc. Class II Classification…	Merit Medical Systems, Inc.	2003	3

Also cleared against K031691: 3 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K130730	V-Stick Vascular Access Set	Argon Medical	2013	1

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?

Its one ancestor has a recall.
Of its descendants, K130730 (Argon Medical, 2013) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K031691.

How does its category compare?

All DRE devices

DRE Dilator, Vessel, For Percutaneous Catheterization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · DRE

3in 2025

2007high 6 (2014) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRE

31in 2025

2007high 261 (2022) · low 30 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRE

1in 2016

2007high 2 (2009) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DRE

356in 2025

2007high 386 (2023) · low 38 (2008)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/K091584 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091584: Merit Mak (Mini Access Kit) with Palladium Tip Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091584

Report an extraction error

Are you the manufacturer?

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