510(k) · Cleared

Recalled · Class II · 2018

Concentric Balloon Guide Catheter

K112404510(k) TraditionalCleared Mar 15, 2012206-day reviewClass II21 CFR 870.1250Recalls 1

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

Concentric Medical, Inc. · DQY Catheter, Percutaneous

Cleared on Mar 15, 2012 as substantially equivalent to K102657 (Concentric Medical, Inc., 2010) after a 206-day review. Its family tree reaches back 3 generations to 2001. 47 later devices descend from it. It has been recalled once.

Decided: Mar 15, 2012
Review: 206 days
Class: Class II
Product code: DQY
Recalls: 1
Predicates: 1

Its longest line of descent runs back 3 generations to K010954 (2001). 47 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
2 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
1 generation backK102657 Concentric Balloon Guide CatheterConcentric Medical, Inc. · 2010
This deviceK112404 Concentric Balloon Guide CatheterConcentric Medical, Inc. · 2012
Descendant · cites it directly · 28 of its ownK133177 Modified HD Guide CatheterConcentric Medical, Inc. · 2014 · Recalled
Descendant · 2 generations on · 26 of its ownK151667 AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal…Stryker · 2015 · Recalled
Descendant · 3 generations on · 19 of its ownK180715 React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018
Descendant · cites it directly · 15 of its ownK122581 Modified Balloon Guide Catheter Model 90253, 90254Concentric Medical, Inc. · 2012 · Recalled
Descendant · 3 generations on · 14 of its ownK183463 AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal…Stryker · 2019

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2012high 8 (2024) · low 0 (2017)2026

Most influential descendants

Showing 5 of 47 · See all

K133177Modified HD Guide CatheterConcentric Medical, Inc. · 2014 · cites it directly28descendants
K151667AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter…Stryker · 2015 · 2 generations on26descendants
K180715React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018 · 3 generations on19descendants
K122581Modified Balloon Guide Catheter Model 90253, 90254Concentric Medical, Inc. · 2012 · cites it directly15descendants
K183463AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068…Stryker · 2019 · 3 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K010954	Concentric Balloon Guide Catheter, Model 90031	Concentric Medical, Inc.	2001	1
−2	K021899	Concentric Balloon Guide Catheter, Model 90072	Concentric Medical, Inc.	2002	1
−1	K102657	Concentric Balloon Guide Catheter	Concentric Medical, Inc.	2010	—
0 (this device)	K112404	Concentric Balloon Guide Catheter	Concentric Medical, Inc.	2012	—
+1	K133177	Modified HD Guide Catheter	Concentric Medical, Inc.	2014	3
+2	K151667	AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access…	Stryker	2015	3
+3	K180715	React 68 Catheter	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	2018	—
+1	K122581	Modified Balloon Guide Catheter Model 90253, 90254	Concentric Medical, Inc.	2012	1
+3	K183463	AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access…	Stryker	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2014	1	0
2015	1	0
2016	1	0
2018	2	0
2019	5	0
2020	4	0
2021	4	0
2022	3	0
2023	5	0
2024	8	0
2025	5	0
2026	6	0

FIG. 1 — Lineage of K112404, 2001–2026Source: 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.

Planning a device in DQY? 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
*	K102657	Concentric Balloon Guide Catheter Summary page 1 …Senior Vice President, Technology and Regulatory Affairs Date Prepared August 4, 2011 Predicate Device Concentric Balloon Guide Catheters (K1 02657) Device Description The Concentric Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters des…	Concentric Medical, Inc.	2010	—

What descends from it? (47)

See all 47

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K133177	Modified HD Guide Catheter	Concentric Medical, Inc.	2014	28
K122581	Modified Balloon Guide Catheter Model 90253, 90254	Concentric Medical, Inc.	2012	15
K131492	Modified Flowgate Balloon Guide Catheter	Concentric Medical, Inc.	2013	13
K220331	091 Balloon Guide Catheter	Inneuroco, Inc.	2022	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 13, 2018	Class II	Z-0065-2020	Labeling False and Misleading	Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
2 of the 3 ancestors have a recall of any class.
Of its descendants, K133177 (Concentric Medical, Inc., 2014) has gone furthest, with 28 descendants of its own.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112404 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112404: Concentric Balloon Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112404

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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