510(k) · Cleared

Cleared

The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology

K181563510(k) TraditionalCleared Sep 26, 2018104-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

Access Scientific, LLC · DQY Catheter, Percutaneous

Cleared on Sep 26, 2018 as substantially equivalent to K171146 (Arrow International, Inc. (Subsidiary of Telelflex Inc.), 2017) after a 104-day review. Its family tree reaches back 3 generations to 1981. 2 of the 4 devices in its family, counting itself, have a Class I recall.

Decided: Sep 26, 2018
Review: 104 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

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

By dateBy generation

Root · 3 generations backK810675 Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · Recalled (Class I)
2 generations backK093050 Arrow Seldinger Arterial Catherization Devices, Models EX Sac 00520Arrow Intl., Inc. · 2009
1 generation backK171146 Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow…Arrow International, Inc. (Subsidiary of Telelflex Inc.) · 2017 · Recalled (Class I)
This deviceK181563 The ARTERIAL WAND Safety Introducer with Arterial Catheter made of…Access Scientific, LLC · 2018

Class I recalls in this family

K171146 Arrow Seldinger Arterial Catheterization Device…direct predicate · 2017
K810675 Arrow Radial Artery Catheterization Set3 generations back · 1981

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K810675	Arrow Radial Artery Catheterization Set	Arrow Intl., Inc.	1981	Class I
−2	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
0 (this device)	K181563	The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex…	Access Scientific, LLC	2018	—

FIG. 1 — Lineage of K181563, 1981–2018Source: 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
*	K171146	Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial… Summary page 5 …WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is substantially equivalent to the following predicate device: • K171146 – Arrow Seldinger Arterial Catheterization Device 4. REFERENCE DEVICE IDENTIFICATION The ARTERIAL WAND™ Safety Introducer with…	Arrow International, Inc. (Subsidiary of Telelflex Inc.)	2017	Class I
†	K162322	the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model	Access Scientific, LLC	2016	—
†	K052564	Vygon Leader-Flex	Vygon Corp.	2006	—

Also cleared against K171146: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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.

K171146Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20…Arrow International, Inc. (Subsidiary of Telelflex Inc.) · 2017 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
2 of the 3 ancestors have a recall of any class; 2 have a Class I recall.
1 other device also cites its predicate K171146.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is used to gain access to the vascular (e.g. arterial) system to sample blood, administer fluids, and monitor blood pressure intravascularly.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K181563 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181563: The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181563

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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