510(k) · Cleared

Cleared

Benelli Access Device

K111334510(k) TraditionalCleared Aug 1, 201181-day reviewClass II21 CFR 870.1250

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

Vascular Solutions, Inc. · DQY Catheter, Percutaneous

Cleared on Aug 1, 2011 as substantially equivalent to K021120 (Arrow Intl., Inc., 2002) and 1 other predicate after an 81-day review. Its family tree reaches back 2 generations to 1981. 3 of the 5 devices in its family, counting itself, have a Class I recall.

Decided: Aug 1, 2011
Review: 81 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K810675 (1981). 4 ancestors in all. No later device cites it as a predicate yet. 3 of the 5 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK810675 Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · Recalled (Class I)
1 generation backK021120 Radial Artery Catherization Set with Integral Needle…Arrow Intl., Inc. · 2002 · Recalled (Class I)
This deviceK111334 Benelli Access DeviceVascular Solutions, Inc. · 2011

Class I recalls in this family

K021120 Radial Artery Catherization Set with Integral…direct predicate · 2002
K003006 Two-Lumen Picc with Blue Flextip Catheter and…2 generations back · 2000
K810675 Arrow Radial Artery Catheterization Set2 generations back · 1981

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K810675	Arrow Radial Artery Catheterization Set	Arrow Intl., Inc.	1981	Class I
−1	K021120	Radial Artery Catherization Set with Integral Needle Protection,Model…	Arrow Intl., Inc.	2002	Class I
0 (this device)	K111334	Benelli Access Device	Vascular Solutions, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	1
2004	1	0

FIG. 1 — Lineage of K111334, 1981–2011Source: 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.

3 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 DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

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
*	K021120	Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SP Summary page 1 …Device Common / Usual Name Catheter, percutaneous Classification Name 870.1250; DQY; Percutaneous catheter; Class 11 Predicate Devices K021 120 Arrow Arterial Catheterization Device (Arrow International, Inc. K0…	Arrow Intl., Inc.	2002	Class I
*	K032843	Nexiva Closed IV Catheter System Summary page 1 …11 Predicate Devices K021 120 Arrow Arterial Catheterization Device (Arrow International, Inc. K032843 Nexiva Closed IV Catheter System (Becton Dickinson Infusion Therapy Systems, Inc.)…	Becton Dickinson Infusion Therapy Systems, Inc.	2004	17

Also cleared against K021120: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (3 Class I)

No FDA recall names this device.

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.

K021120Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SPArrow Intl., Inc. · 2002 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K003006Two-Lumen Picc with Blue Flextip Catheter and Integral Needle ProtectionArrow Intl., Inc. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 21.1 years on median.
4 of the 4 ancestors have a recall of any class; 3 have a Class I recall.
2 other devices also cite its predicate K021120.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

What is it indicated for?

The Benelli is intended for use in accessing the peripheral vasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111334 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111334: Benelli Access Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111334

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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