510(k) · Cleared

Cleared

Arrow Seldinger Arterial Catherization Devices, Models EX Sac 00520

K093050510(k) SpecialCleared Dec 18, 200979-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

Arrow Intl., Inc. · DQY Catheter, Percutaneous

Cleared on Dec 18, 2009 as substantially equivalent to K810675 (Arrow Intl., Inc., 1981) after a 79-day review. Its family tree reaches back 1 generation to 1981. 2 of the 5 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.

Decided: Dec 18, 2009
Review: 79 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K810675 (1981). 3 later devices descend from it, 1 citing it directly. 2 of the 5 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 deviceK093050 Arrow Seldinger Arterial Catherization Devices, Models EX Sac 00520Arrow Intl., Inc. · 2009
Descendant · cites it directly · 2 of its ownK171146 Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow…Arrow International, Inc. (Subsidiary of Telelflex Inc.) · 2017 · Recalled (Class I)
Descendant · 2 generations on · 0 of its ownK201726 Arterial CatheterHaolang Medical USA Corporation · 2021
Descendant · 2 generations on · 0 of its ownK181563 The ARTERIAL WAND Safety Introducer with Arterial Catheter made of…Access Scientific, LLC · 2018

Class I recalls in this family

K810675 Arrow Radial Artery Catheterization Setdirect predicate · 1981
K171146 Arrow Seldinger Arterial Catheterization Device…cites it directly · 2017

Most influential descendants

Showing 3 of 3 · See all

K171146Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial…Arrow International, Inc. (Subsidiary of Telelflex Inc.) · 2017 · cites it directly2descendants
K201726Arterial CatheterHaolang Medical USA Corporation · 2021 · 2 generations on0descendants
K181563The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with…Access Scientific, LLC · 2018 · 2 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)	K093050	Arrow Seldinger Arterial Catherization Devices, Models EX Sac 00520	Arrow Intl., Inc.	2009	—
+1	K171146	Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger…	Arrow International, Inc. (Subsidiary of Telelflex Inc.)	2017	Class I
+2	K201726	Arterial Catheter	Haolang Medical USA Corporation	2021	—
+2	K181563	The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex…	Access Scientific, LLC	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	1
2018	1	0
2021	1	0

FIG. 1 — Lineage of K093050, 1981–2021Source: 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.

2 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? (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
*	K810675	Arrow Radial Artery Catheterization Set Summary page 1 …de, Catheter, 21 CFR 870.1330 Legaily marketed device to which the device Is Arrow Radial Artery Catheterization Set, K810675 substantially equivalent. Description of the device: The Arrow Seldinger arterial ca…	Arrow Intl., Inc.	1981	Class I

Also cleared against K810675: 8 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K171146	Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial… Class I	Arrow International, Inc. (Subsidiary of Telelflex Inc.)	2017	2

Has anything in its family been recalled? (2 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.

K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K171146Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20…Arrow International, Inc. (Subsidiary of Telelflex Inc.) · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has a recall, Class I.
Of its descendants, K171146 (Arrow International, Inc. (Subsidiary of Telelflex Inc.), 2017) has gone furthest, with 2 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. 2009, 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 Arrow® Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093050 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093050: Arrow Seldinger Arterial Catherization Devices, Models EX Sac 00520.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093050

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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