510(k) · Cleared

Recalled · Class I · 2024

Route 92 Medical Delivery Catheter

K190431510(k) SpecialCleared Mar 21, 201927-day reviewClass II21 CFR 870.1250Recalls 1 (1 Class I)

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

Route 92 Medical, Inc. · DQY Catheter, Percutaneous

Cleared on Mar 21, 2019 as substantially equivalent to K182512 (Route 92 Medical, Inc., 2018) after a 27-day review. Its family tree reaches back 1 generation to 2018. 1 of the 2 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.

Decided: Mar 21, 2019
Review: 27 days
Class: Class II
Product code: DQY
Recalls: 1 (1 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to K182512 (2018). 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 backK182512 Route 92 Medical Delivery CatheterRoute 92 Medical, Inc. · 2018
This deviceK190431 Route 92 Medical Delivery CatheterRoute 92 Medical, Inc. · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K182512	Route 92 Medical Delivery Catheter	Route 92 Medical, Inc.	2018	—
0 (this device)	K190431	Route 92 Medical Delivery Catheter	Route 92 Medical, Inc.	2019	—

FIG. 1 — Lineage of K190431, 2018–2019Source: 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
*	K182512	Route 92 Medical Delivery Catheter Summary page 4 …theter (Product Code DQY, 21 CFR 870.1250) Legally Marketed Predicate Device: Route 92 Medical Delivery Catheter (K182512) Device Description The modified Route 92 Medical Delivery Catheter is a single-lumen, variable stiffness, hydrophilically coate…	Route 92 Medical, Inc.	2018	—

Also cleared against K182512: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 8, 2024	Class I	Z-1613-2024	Process control	Their is the potential for distal tip separation at the proximal marker band of the delivery catheters

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
1 other device also cites its predicate K182512.

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?

The Route 92 Medical Delivery Catheter is indicated for use with compatible catheters in facilitating the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K190431 · printed Nov 6, 2026

Cite this page

510(k) Report. “K190431: Route 92 Medical Delivery Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190431

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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