510(k) · Cleared

Cleared

Asahi Sasuke

K182844510(k) TraditionalCleared Jun 22, 2019256-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

Asahi Intecc Co., Ltd. · DQY Catheter, Percutaneous

Cleared on Jun 22, 2019 as substantially equivalent to K060327 (Vascular Solutions, Inc., 2006) after a 256-day review. Its family tree reaches back 1 generation to 2006. 1 of the 2 devices in its family, counting itself, has a Class I recall.

Decided: Jun 22, 2019
Review: 256 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K060327 (2006). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK060327 Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support…Vascular Solutions, Inc. · 2006 · Recalled (Class I)
This deviceK182844 Asahi SasukeAsahi Intecc Co., Ltd. · 2019

Class I recalls in this family

K060327 Vascular Solutions Twin-Pass Dual Access…direct predicate · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K060327	Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support Catheter	Vascular Solutions, Inc.	2006	Class I
0 (this device)	K182844	Asahi Sasuke	Asahi Intecc Co., Ltd.	2019	—

FIG. 1 — Lineage of K182844, 2006–2019Source: 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.

1 device in this family has 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
*	K060327	Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support Catheter Summary page 4 …ION: CLASSIFICATION Percutaneous Catheter NAME: PRODUCT CODE DQY- Catheter, Percutaneous PREDICATE DEVICE: Twin-Pass Dual Access Catheter (K060327) REFERENCE DEVICE ASAHI Caravel (K152447) INDICATIONS FOR USE FOR THE ASAHI SASUKE® This product is intended to be us…	Vascular Solutions, Inc.	2006	Class I
†	K152447	ASAHI Caravel	Asahi Intecc Co., Ltd.	2016	—

Also cleared against K060327: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 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.

K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · 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.
6 other devices also cite its predicate K060327.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?

This product is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary arterial vasculature and peripheral vessels, to facilitate placement of guidewires and other interventional devices, for use during two guidewire procedures, and to subselectively infuse/deliver diagnostic or therapeutic agents. Not for use in the neurovasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K182844 · printed Nov 4, 2026

Cite this page

510(k) Report. “K182844: Asahi Sasuke.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182844

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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