510(k) · Cleared

Recalled · Class I · 2026

Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SP

K021120510(k) SpecialCleared May 2, 200224-day reviewClass II21 CFR 870.1250Recalls 2 (1 Class I)

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

Arrow Intl., Inc. · DQY Catheter, Percutaneous

Cleared on May 2, 2002 as substantially equivalent to K810675 (Arrow Intl., Inc., 1981) and 1 other predicate after a 24-day review. Its family tree reaches back 1 generation to 1981. 4 of the 10 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled 2 times, including a Class I recall.

Decided: May 2, 2002
Review: 24 days
Class: Class II
Product code: DQY
Recalls: 2 (1 Class I)
Predicates: 2

Its longest line of descent runs back 1 generation to K810675 (1981). 2 ancestors in all. 7 later devices descend from it, 3 citing it directly. 4 of the 10 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK810675 Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · Recalled (Class I)
This deviceK021120 Radial Artery Catherization Set with Integral Needle…Arrow Intl., Inc. · 2002
Descendant · cites it directly · 4 of its ownK151513 Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow Internation, Inc. (Subsidiary of Teleflex Inc.) · 2015 · Recalled
Descendant · 2 generations on · 3 of its ownK152272 Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015
Descendant · 2 generations on · 2 of its ownK163513 Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2017 · Recalled (Class I)
Descendant · 3 generations on · 0 of its ownK243599 Arrow™ Endurance™ Extended Dwell Peripheral Catheter System…Arrow International, LLC (A subsidiary of Teleflex, Inc.) · 2025
Descendant · 3 generations on · 0 of its ownK242281 Arrow Endurance Extended Dwell Peripheral Catheter System…Arrow International, LLC (A subsidiary of Teleflex, Inc.) · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2007high 2 (2015) · low 0 (2008)2026

Class I recalls in this family

K003006 Two-Lumen Picc with Blue Flextip Catheter and…direct predicate · 2000
K810675 Arrow Radial Artery Catheterization Setdirect predicate · 1981
K163513 Arrow Endurance Extended Dwell Peripheral…2 generations on · 2017

Most influential descendants

Showing 5 of 7 · See all

K151513Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow Internation, Inc. (Subsidiary of Teleflex Inc.) · 2015 · cites it directly4descendants
K152272Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · 2 generations on3descendants
K163513Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2017 · 2 generations on2descendants
K243599Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)Arrow International, LLC (A subsidiary of Teleflex, Inc.) · 2025 · 3 generations on0descendants
K242281Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance…Arrow International, LLC (A subsidiary of Teleflex, Inc.) · 2024 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K810675	Arrow Radial Artery Catheterization Set	Arrow Intl., Inc.	1981	Class I
0 (this device)	K021120	Radial Artery Catherization Set with Integral Needle Protection,Model…	Arrow Intl., Inc.	2002	—
+1	K151513	Arrow Endurance Extended Dwell Peripheral Catheter System	Arrow Internation, Inc. (Subsidiary of Teleflex Inc.)	2015	1
+2	K152272	Arrow Endurance Extended Dwell Peripheral Catheter System	Arrow International, Inc. (Subsidiary of Teleflex, Inc.)	2015	—
+2	K163513	Arrow Endurance Extended Dwell Peripheral Catheter System	Arrow International, Inc. (Subsidiary of Teleflex, Inc.)	2017	Class I
+3	K243599	Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)	Arrow International, LLC (A subsidiary of Teleflex, Inc.)	2025	—
+3	K242281	Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow…	Arrow International, LLC (A subsidiary of Teleflex, Inc.)	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2011	1	0
2015	2	0
2017	1	1
2024	1	0
2025	1	0

FIG. 1 — Lineage of K021120, 1981–2025Source: 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.

4 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

Get a 510(k) Report

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
*	K810675	Arrow Radial Artery Catheterization Set Summary page 1 …2 Radial Artery Catheterization Set with Integral Needle Protection. Radial artery catheterization set. Percutaneous catheter Arrow Radial Artery Catheterization Set (K810675), and the Arrow PICC Two-lumen Peripherally-inserted Central Catheter Kit with Blue Flex Tip® Catheter and Integral Needle Protec…	Arrow Intl., Inc.	1981	Class I
*	K003006	Two-Lumen Picc with Blue Flextip Catheter and Integral Needle Protection Our OCR of the scanned summary read K000306, FDA’s number for Pinnacle Acetabular System (DePuy Orthopaedics, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Arrow PICC Two-lumen Peripherally-inserted Central Catheter Kit with…”.	Arrow Intl., Inc.	2000	Class I

Also cleared against K810675: 8 other devices →

What descends from it? (7)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K151513	Arrow Endurance Extended Dwell Peripheral Catheter System	Arrow Internation, Inc. (Subsidiary of Teleflex Inc.)	2015	4
K111334	Benelli Access Device	Vascular Solutions, Inc.	2011	0
K071998	Arrow Echogenic Introducer Needle Component	Arrow Intl., Inc.	2007	0

Has anything in its family been recalled? (4 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 21, 2026	Class I	Z-2377-2026	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-1973-2018	Under Investigation by firm	Product sterility may be compromised due to unsealed packaging.

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.

K003006Two-Lumen Picc with Blue Flextip Catheter and Integral Needle ProtectionArrow Intl., Inc. · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K163513Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall

What does this lineage say?

2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K151513 (Arrow Internation, Inc. (Subsidiary of Teleflex Inc.), 2015) has gone furthest, with 4 descendants of its own.
8 other devices also cite its predicate K810675.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Arrow arterial catheterization device permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K021120 · printed Nov 3, 2026

Cite this page

510(k) Report. “K021120: Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K021120

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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