510(k) · Cleared

Recalled · Class I · 2026

Arrow Quickflash Arterial Catheterization Device

K160018510(k) TraditionalCleared Jun 13, 2016160-day reviewClass II21 CFR 870.1330Recalls 2 (2 Class I)

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

Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · DQX Wire, Guide, Catheter

Cleared on Jun 13, 2016 as substantially equivalent to K810675 (Arrow Intl., Inc., 1981) after a 160-day review. Its family tree reaches back 1 generation to 1981. 2 of the 2 devices in its family, counting itself, have a Class I recall. It has been recalled 2 times, including 2 Class I recalls.

Decided: Jun 13, 2016
Review: 160 days
Class: Class II
Product code: DQX
Recalls: 2 (2 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to K810675 (1981). No later device cites it as a predicate yet. 2 of the 2 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 deviceK160018 Arrow Quickflash Arterial Catheterization DeviceArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016

Class I recalls in this family

K810675 Arrow Radial Artery Catheterization Setdirect predicate · 1981

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)	K160018	Arrow Quickflash Arterial Catheterization Device	Arrow International, Inc. (Subsidiary of Teleflex, Inc.)	2016	—

FIG. 1 — Lineage of K160018, 1981–2016Source: 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 DQX device

#1 K213854 SavvyWirescore 15.7 · 10 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 4 …Name: Catheter guide wire, (Class II, DQX, 21 CFR 870.1330) Percutaneous catheter, (Class II, DQY, 21 CFR 870.1250) 3. Predicate Devices • K810675: Arrow® Radial Artery Catheterization Set 4. Device Description The primary purpose of this Traditional 510(k) submission is…	Arrow Intl., Inc.	1981	Class I

Also cleared against K810675: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 21, 2026	Class I	Z-2397-2026	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…
Feb 12, 2024	Class I	Z-1267-2024	Process control	Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire handle/chamber during use.…

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

What does this lineage say?

Its one ancestor has a recall, Class I.
8 other devices also cite its predicate K810675.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · DQX

10in 2025

2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007high 212 (2022) · low 43 (2011)2026

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

Recalls per year · DQX

3in 2024

2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, 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	14	85	12	760
2008	19	87	7	715
2009	18	87	49	687
2010	21	63	34	987
2011	18	43	3	1,311
2012	20	62	5	1,337
2013	18	119	7 (4)	1,474
2014	18	103	0	1,323
2015	15	112	1	1,323
2016	14	179	2 (2)	1,466
2017	19	85	17	1,524
2018	19	114	9	1,737
2019	13	173	2	1,679
2020	14	106	1 (1)	1,536
2021	6	161	0	1,713
2022	15	212	0	1,647
2023	10	136	0	2,068
2024	11	134	3	2,210
2025	10	177	0	2,178
2026	12	145	4 (1)	—

What is it indicated for?

The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K160018 · printed Nov 5, 2026

Cite this page

510(k) Report. “K160018: Arrow Quickflash Arterial Catheterization Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160018

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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